Suspended

Rituximab Plus CAMPATH in Patients With Relapsed/Refractory Low-Grade or Follicular, CD20-positive, B-cell NHL

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What is being tested

CAMPATH (alemtuzumab)

Drug
Who is being recruted

Non-Hodgkin's Lymphoma

Over 18 Years
+23 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: December 2003

See protocol details

Summary

Principal SponsorGenzyme, a Sanofi Company
Last updated: March 26, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2003Actual date on which the first participant was enrolled.

The purpose of this study is to determine the optimal dose of subcutaneous CAMPATH when used in combination with rituximab for patients with relapsing or refractory, low-grade or follicular, CD-20-positive, B-Cell non-Hodgkin's Lymphoma. Safety will be the primary objective of phase I, while the primary objective of phase II will be to determine overall response. This study is being conducted in 2 parts. Phase I will involve dose escalation of subcutaneous CAMPATH (SQ) given 3 times per week in combination with weekly doses of rituximab (375mg/m2) for a maximum of 8 weeks in order to determine the maximum tolerated dose (MTD). In Phase II patients will be treated with SQ CAMPATH at the MTD plus weekly rituximab (375mg/m2)for a maximum of 8 weeks with primary objective of defining Overall Response (OR) to this combination.

Official TitlePhase I/II Study of Rituximab Plus CAMPATH in Patients With Previously Treated Relapsed or Refractory Low-Grade Follicular, CD20-positive, B-cell Non-Hodgkin's Lymphoma 
Principal SponsorGenzyme, a Sanofi Company
Last updated: March 26, 2015
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
49 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
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different 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 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
Non-Hodgkin's Lymphoma
Criteria
7 inclusion criteria required to participate
For the Phase I portion of the study, patients must have pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma that has relapsed or is refractory. For the Phase II portion of the study, patients must have a pathologically confirmed diagnosis of low-grade or follicular, CD20-positive, B-cell, non-Hodgkin's lymphoma (Follicular, predominantly small cleaved or follicular, mixed small cleaved and large cell, International Working Formulation classification B or C or REAL classification follicular center grade 1,2) that has relapsed or is refractory
Previously treated with at least one anti-cancer regimen for NHL
Measurable disease (lesions that can be accurately measured in 2 dimensions by CT scan with a greatest transverse diameter of >/= to 2cm or palpable lesions with both diameters of 2cm or more)
Life expectancy of at least 12 weeks

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16 exclusion criteria prevent from participating
Prior combination therapy with rituximab and CAMPATH; prior therapy with either agent alone is permitted
A history of a T-cell lymphoma
Known AIDS-related HIV-positive lymphoma
For the Phase II portion of the study (once MTD has been determined), bulky disease, ie, any single mass >10cm or circulating malignant cells of 25,000/uL or more

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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 10 locations
Suspended
Unknown FacilityColorado Springs, United StatesSee the location
Suspended
Unknown FacilityOcala, United States
Suspended
Unknown FacilityPark Ridge, United States
Suspended
Unknown FacilityLafayette, United States
Suspended10 Study Centers