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Allogeneic Blood Stem Cell Transplantation and Adoptive Immunotherapy for Hodgkin's Disease

NCT00385788 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2018-05-09

Study results available
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Summary

The goal of this clinical research study is to learn if fludarabine, melphalan and gemcitabine followed by transplantation of stem cells (blood-forming cells) as well as immune cells (lymphocytes), collected from a matched related (i.e. a sibling) or unrelated donor, or a mismatched related donor, can help to control Hodgkin's disease. The safety of the treatment will also be studied.

Conditions

  • Hodgkin's Disease

Interventions

DRUG

Gemcitabine

800 mg/m\^2 IV over 30 minutes on Day -7 (1 day)

DRUG

Fludarabine

33 mg/m\^2 IV over 30 minutes Day -5 to Day -2 (4 days)

DRUG

Melphalan

70 mg/m\^2 IV over 30 minutes on Day -3 to Day -2 (2 days)

DRUG

Antithymocyte Globulin

2 mg/kg IV on Day -4 and Day -3 (2 days) before stem cell transplantation. If receiving transplant from matched unrelated donor (not a blood relative), a mismatched related donor (a blood relative, but not a full match), or receiving a cord blood transplant.

PROCEDURE

Allogeneic Stem Cell Infusion

Infusion of stem cells on Day 0.

DRUG

Tacrolimus

0.03 mg/kg beginning Day -2 by vein over 24 hours; when tolerable change to pill form given once daily for 3-4 months.

DRUG

Filgrastim (G-CSF)

Starting 1 week after transplant (Day +7) given as injection under the skin once daily until blood cell levels return to normal.

DRUG

Methotrexate

5 mg/m2 by vein on Days +1, +3, +6, and +11 to decrease risk of GVHD.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Paolo Anderlini, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385788 on ClinicalTrials.gov