Completed

Phase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia

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What is being tested

rituximab

+ cyclophosphamide
+ pentostatin
Biological
Drug
Who is being recruted

Chronic Disease
+11

+ Hematologic Diseases
+ Immune System Diseases
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: April 2005
See protocol details

Summary

Principal SponsorEastern Cooperative Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 14, 2005Actual date on which the first participant was enrolled.

OBJECTIVES: Primary * Determine the objective response rate (complete remission, partial remission \[PR\], or nodular PR) in patients with relapsed or refractory B-cell chronic lymphocytic leukemia (CLL) treated with pentostatin, cyclophosphamide, and rituximab (PCR) followed by CAMPATH-1H . * Determine the presence of minimal residual disease in patients treated with this regimen who achieve a CR or nPR Secondary * Determine the toxicity of this regimen in these patients. * Determine the overall and progression-free survival of patients treated with this regimen. * Evaluate the number of patients who after PCR (or during PCR for PD), only achieve a PR, SD, or PD and who subsequently convert to a higher response category after CAMPATH-1H . Exploratory * Assess the angiogenic profile (i.e., secretion levels of pro- versus anti-angiogenic molecules) of CLL B cell clones as well as bone marrow angiogenesis (i.e., vascular density by immunohistochemistry) at baseline, after PCR, after CAMPATH-1H, every six months (serum only), and at time of response assessment (marrow). * Determine the V_H gene mutation status and CD38 expression of the B-CLL clones at study entry and at the end of the therapy and assess the association between the VH gene mutation status and CD38 expression and clinical outcome. * Determine surface phenotype (by flow cytometry) and genetic defects (by CLL FISH panel) information on CLL-B cell clones and associate with clinical outcome. * Monitor the T-cell status by repertoire and flow cytometry analysis to determine the nature and extent of T-cell deficiency induced by the PCR and CAMPATH-1H treatment and assess any association with clinical outcome and toxicities.

Official TitlePhase II Trial of Pentostatin, Cyclophosphamide and Rituximab (PCR) Followed by Campath-1H for Previously Treated Relapsed or Refractory Patients With Chronic Lymphocytic Leukemia 
NCT00074282
Principal SponsorEastern Cooperative Oncology Group
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
102 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment
: Everyone gets the same treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled
: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Chronic Disease
Hematologic Diseases
Immune System Diseases
Immunoproliferative Disorders
Leukemia
Leukemia, Lymphoid
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Disease Attributes
Criteria

Inclusion criteria: * Diagnosis of B-cell chronic lymphocytic leukemia (CLL) meeting the following criteria: * Peripheral blood absolute lymphocyte count greater than 5,000/mm\^3 * Lymphocytosis must comprise small to moderate size lymphocytes with no greater than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically * Phenotypically characterized CLL defined by the following: * Predominant population of cells share B-cell antigens with CD5 in the absence of other pan-T-cell markers (CD3 or CD2) * B cell expresses either kappa or lambda light chains * Surface immunoglobulin with low cell surface density expression * Requires chemotherapy, as indicated by any of the following: * Disease-related symptoms * Weight loss of 10% or more within the past 6 months * Extreme fatigue * Fevers greater than 100.5°F for 2 weeks without evidence of infection * Night sweats without evidence of infection * Evidence of progressive marrow failure manifested by the development of or worsening anemia (hemoglobin no greater than 10 g/dL) and/or thrombocytopenia (platelet count no greater than 100,000/mm\^3) * Massive (i.e., greater than 6 cm below left costal margin) or progressive splenomegaly * Massive nodes or clusters (i.e., greater than 10 cm in longest diameter) or progressive adenopathy * Progressive lymphocytosis with an increase of greater than 50% over a 2-month period OR an anticipated doubling time of less than 6 months * Demonstrated progression after at least 1 course of either an alkylating agent-based or purine nucleoside-based (e.g., fludarabine) regimen OR failed to achieve a meaningful response OR relapsed after prior therapy * Patients who have relapsed after a pentostatin-based regimen are eligible provided the response was greater than 12 months prior to study entry * 18 and over * ECOG Performance Status 0-2 * Bilirubin no greater than 2 mg/dL (unless secondary to tumor, hemolysis, or Gilbert syndrome) * Creatinine no greater than 2.0 mg/dL * Creatinine clearance ≥ 30 mL/min * Negative pregnancy test * Fertile patients must use 2 methods of effective contraception (including 1 barrier method) for at least 28 days before starting lenalidomide, while participating in the study, and for at least 28 days after discontinuation/stopping lenalidomide * At least 8 weeks since prior rituximab * At least 6 weeks since prior chemotherapy * At least 1 year since prior pentostatin, cyclophosphamide, and rituximab (PCR) therapy * PCR therapy at least 1 year prior to study entry allowed Exclusion criteria: * Bone marrow dysplasia related to prior therapy * New York Heart Association class III or IV heart failure * Prior lenalidomide * Other malignancy within the past 2 years except squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * Pregnant or nursing * Concurrent oral or IV antibiotics for active infection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Treatment consisted of 6 cycles of pentostatin, cyclophosphamide, and rituximab (PCR) given every 28 days. Rituximab administered as follows: For the first infusion, all patients receive 100 mg dose (regardless of weight/BSA). For subsequent infusions, all patients receive rituximab 375 mg/m2. Pentostatin and cyclophosphamide administered as follows: Pentostatin given at 4 mg/m2 either as an IV push or IV over 10-30 minutes in 250 mL NS or D5W on day 1 every 4 weeks of cycles 1-6. Cyclophosphamide given at 600 mg/m2 IV over 30-60 minutes in 250 mL NS on day 1 every 4 weeks of cycle 1-6.

Group II
Experimental
Patients who achieved a confirmed CR or nPR, were registered to receive Alemtuzumab (Arm B). When the patient was registered to Arm B, the drug was administered three times a week for four weeks. The dose was 30 mg per dose. A twelve-week treatment-free period had to elapse before CAMPATH-1H began following completion of PCR for Arm B patients

Group III
Experimental
For those patients not achieving a CR or nPR (thus patients either achieved PR, SD, or PD), Alemtuzumab (Arm C) was administered three times a week for eighteen weeks at a dose of 30 mg TIW. For PR, SD and PD patients, the timing of CAMPATH-1H was left to the discretion of the investigator, and treatment could begin earlier but no less than two weeks and no longer than eight weeks after the completion of the last PCR course. Patients determined to have PD during treatment with PCR did not need to complete all 6 cycles of PCR to go on to Arm C, however, completing a minimum of 2 cycles was required.

Study Objectives
Primary Objectives

Percent of patients who have MCR (clinical CR with flow negative and RT-PCR negative)

Percent with response (CR, nPR, PR) with two-stage 90% confidence interval
Secondary Objectives

OS is defined as the time from registration until death from any cause.

PFS is defined as the time from registration until induction failure, institution of non-protocol therapy, relapse or death from any cause in the absence of relapse.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 143 locations
Suspended
Mayo Clinic ScottsdaleScottsdale, United StatesSee the location
Suspended
Aurora Presbyterian HospitalAurora, United States
Suspended
Boulder Community HospitalBoulder, United States
Suspended
Penrose Cancer Center at Penrose HospitalColorado Springs, United States
Completed143 Study Centers