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Cytolytic T-lymphocytes

Anti-Third Party T Lymphocytes + Nonmyeloablative SCT for Leukemia

Phase 1

Waitlist Available

Led By Richard E. Champlin, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 90 days

Awards & highlights

No Placebo-Only Group

Approved for 20 Other Conditions

All Individual Drugs Already Approved

Summary

Primary Objective: 1. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1. Toxicity, response rate, time to progression and overall survival.

Eligible Conditions

Leukemia
Multiple Myeloma
Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximally tolerated dose of anti-third party cytolytic T-lymphocytes

Number of Participants achieving engraftment without severe Graft-versus-host disease (GVHD)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Anti-Third Party T Lymphocytes + Nonmyeloablative SCTExperimental Treatment8 Interventions

Anti-Third Party CTL (Cytolytic T-lymphocytes) with Nonmyeloablative SCT (Stem Cell Transplantation) Rituximab 375 mg/m\^2 intravenously over several hours on Day -13, followed by 1000 mg/m\^2 intravenously on Days -6, 1, and 8; + Cyclophosphamide 50 mg/kg intravenously over two hours on Day -6, immediately following Fludarabine; + Fludarabine 40 mg/m\^2 intravenously over 30 minutes once per day for 4 days, starting Day -6; + Radiation 2Gy Total body radiation day before transplantation + Stem Cell Transplantation + Intravenous infusion of Anti-third Party CTLs.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

FDA approved

Cyclophosphamide

FDA approved

Rituximab

FDA approved

Coenzyme M

FDA approved