A Study to Evaluate the Effect of ATG-F on Engraftment, Graft Versus Host Disease (GVHD) and Graft Versus Leukemia (GVL) Effect in Haplo-identical SCT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-09-30

Brief Summary

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This study is planned to evaluated whether ATG is needed in haploidentical stem cell transplantation

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Detailed Description

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Conditions

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Allogeneic Haplo-Stem Cell Transplatation (SCT) Graft Versus Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

with ATG-F

Group Type EXPERIMENTAL

ATG-F

Intervention Type DRUG

ATG-f

2

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ATG-F

ATG-f

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient age 3-70 years old with a disease necessitating allogeneic SCT.
2. Patients must have a mismatched donor willing and capable of donating peripheral blood stem cells and/or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (mismatched defined as 3/6-4/6 HLA matching).
3. Each patient / patient's guardian must sign written informed consent.
4. Patients must have an ECOG PS ≤ 2; Creatinine \<2.0 mg/dl; Ejection fraction \>40%; DLCO \>50% of predicted; Serum bilirubin \<3 gm/dl; elevated GPT or GOT \>3 x normal values.

2. Active life-threatening infection.
3. Overt untreated infection.
4. Known hypersensitivity to ATG.
5. HIV seropositivity, Hepatitis B or C antigen positivity with evidence of active hepatitis.
6. Pregnant or lactating women.
7. Donor contraindication (HIV seropositive confirmed by Western Blot Hepatitis B antigenemia; positive HCV antibodies with positive HCV PCR; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition).
8. Inability to comply with study requirements.

Minimum Eligible Age

3 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No