Cyclophosphamide Plus T-Cell Transplantation for Patients With Hematologic Malignancies

Phase 1

Terminated

• Conditions: Leukemia; Myelodysplastic Syndromes
• Interventions: Drug: Cyclophosphamide; Biological: Donor T cells

• Registration Number: NCT00356928
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of abnormal blood cells, either by killing the cells or by stopping them from dividing. Giving cyclophosphamide together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for myelodysplastic syndromes or myeloproliferative disorders.

PURPOSE: This clinical trial is studying the best dose of donor lymphocytes when given together with cyclophosphamide in treating patients with myelodysplastic syndromes or myeloproliferative disorders.

Detailed Description

OBJECTIVES:

* Determine the maximum tolerated dose of allogeneic CD8-positive T-cell-depleted, haploidentical donor lymphocytes when given after cyclophosphamide in patients with myelodysplastic syndromes or myeloproliferative disorders.

OUTLINE: Patients receive cyclophosphamide on days 1 and 2. Patients then undergo infusion of allogeneic T-cell depleted donor lymphocytes on day 3.

Cohorts of patients receive escalating doses of CD8-positive T-cell-depleted haploidentical donor lymphocytes until the maximum tolerated dose is determined.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Study Timeline

• Study First Submitted: 2006-07-26
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Study Start: 2006-10
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide + T cells	Cyclophosphamide	Conditioning regimen with cyclophosphamide followed by donor T cells on Day 0.
Cyclophosphamide + T cells	Donor T cells	Conditioning regimen with cyclophosphamide followed by donor T cells on Day 0.

Primary Outcome Measures

Name	Time	Method
Maximum tolerated dose of haploidentical donor lymphocytes	60 days	Maximum dose in cells per kilogram that did not cause dose-limiting toxicity (defined as grade 3-5 non-hematologic toxicity, death within 60 days related to protocol treatment, aplasia related to treatment, or grade 3-4 graft-vs-host-disease).

Secondary Outcome Measures

Name	Time	Method
Disease response	Up to 6 months	Percentage of participants who had a complete remission after protocol treatment.
Duration of response	Up to 6 months	Median length of response (in months) of participants who had a complete remission after protocol treatment.

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States