Completed

A Phase I Study of Photochemically Treated Donor T-Cell Supplements in HLA Haplotype Mismatched Hematopoietic Stem Cell Transplantation

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What is being tested

Cyclophosphamide

+ Psoralen

+ Thiotepa

DrugProcedureRadiation
Who is being recruted

Lymphadenopathy+76

+ Blood Protein Disorders

+ Bone Marrow Diseases

Until 49 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: May 1999
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: October 26, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: May 28, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: I. Determine the maximum tolerated dose of T-cells photochemically treated with psoralen and ultraviolet A given with peripheral stem cell transplantation in patients with hematologic malignancies or bone marrow failure myelodysplastic syndrome. II. Assess the toxicity of this treatment in these patients. III. Evaluate this regimen in terms of prevention of graft versus host disease and control of malignancy in these patients. OUTLINE: This is a dose escalation, multicenter study of T-cells photochemically treated with psoralen and ultraviolet A. Patients receive thiotepa IV over 2 hours on day 1, cyclophosphamide IV over 2 hours on days 2 and 3, and whole body radiotherapy on days 5-8. Patients undergo preserved stem cell or bone marrow allogeneic transplant plus psoralen treated T-cell allogeneic transplant on day 9. Cohorts of 3-6 patients receive escalating doses of photochemically treated T-cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 patients experience dose limiting toxicities. Patients are followed for 100 days. PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.

NCT00005092
Principal SponsorM.D. Anderson Cancer Center
Last updated: October 26, 2018
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

7 patients to be enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 49 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

LymphadenopathyBlood Protein DisordersBone Marrow DiseasesCardiovascular DiseasesCell Transformation, NeoplasticChronic DiseaseDNA Virus InfectionsEye NeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersHerpesviridae InfectionsImmune System DiseasesImmunoproliferative DisordersInfectionsLeukemia, LymphoidLeukemia, MyeloidLymphatic DiseasesLymphoproliferative DisordersMyeloproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplastic ProcessesParaproteinemiasPathologic ProcessesPathological Conditions, Signs and SymptomsTumor Virus InfectionsVascular DiseasesVirus DiseasesLeukemia, B-CellLeukemia, T-CellHistiocytosisHistiocytic Disorders, MalignantLymphoma, B-CellLymphoma, T-CellEpstein-Barr Virus InfectionsHemostatic DisordersDisease AttributesMyelodysplastic-Myeloproliferative DiseasesCarcinogenesisBlast CrisisBurkitt LymphomaLeukemia, Erythroblastic, AcuteHodgkin DiseaseImmunoblastic LymphadenopathyLeukemiaLeukemia, Megakaryoblastic, AcuteLeukemia, Monocytic, AcuteLymphomaLymphoma, FollicularLymphoma, Non-HodgkinMultiple MyelomaMycosis FungoidesMyelodysplastic SyndromesSezary SyndromeLeukemia, Lymphocytic, Chronic, B-CellLeukemia, Biphenotypic, AcuteLeukemia, ProlymphocyticLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, Myeloid, Accelerated PhaseLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Basophilic, AcuteLeukemia, Eosinophilic, AcuteLeukemia, Promyelocytic, AcuteLeukemia, Myelomonocytic, ChronicLeukemia, Myelomonocytic, AcuteLymphoma, Large-Cell, ImmunoblasticLymphoma, Large B-Cell, DiffuseLymphoma, T-Cell, CutaneousLymphoma, Large-Cell, AnaplasticLymphoma, Mantle-CellLeukemia, Large Granular LymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaPrecursor T-Cell Lymphoblastic Leukemia-LymphomaNeoplasms, Plasma CellDendritic Cell Sarcoma, InterdigitatingIntraocular Lymphoma

Criteria

DISEASE CHARACTERISTICS: Hematologic malignancy, including acute myeloid or lymphoid leukemia of any FAB subtype, not in remission with chemotherapy or requiring bone marrow transplant OR Chronic myeloid leukemia, advanced beyond first chronic phase OR Myelodysplasia, including secondary to prior chemotherapy, with: Granulocyte count less than 500/mm3 OR Platelet count less than 50,000/mm3 OR High risk cytogenetic abnormalities such as +8, -7, -5, or 11q23 OR Intermediate or high grade lymphoma without response to initial therapy or in relapse OR Multiple myeloma without response to initial therapy or in relapse OR Stage IV low grade lymphoma or chronic lymphocytic leukemia not achieving remission with 2 regimens No aplastic anemia Related haploidentical donor (1-3 HLA-A, B, and/or DR mismatch) for collection of stem cells and whole blood T-cells required PATIENT CHARACTERISTICS: Age: 6 months to 49 years Performance status: ECOG 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 3 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL Cardiovascular: Left ventricular ejection fraction at least 45% No symptoms or active treatment of left ventricular failure Pulmonary: Corrected DLCO at least 50% Other: No acute viral, bacterial, or fungal infection No prior transfusion associated graft versus host disease No other medical condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy or interferon alfa and recovered No prior autologous or allogeneic progenitor cell transplant Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: Not specified

Study Plan

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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation

Study Objectives

Primary Objectives

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 3 locations

University of Illinois at Chicago

Chicago, United StatesOpen University of Illinois at Chicago in Google Maps

Washington University Barnard Cancer Center

St Louis, United States

University of Texas - MD Anderson Cancer Center

Houston, United States
Completed3 Study Centers