Thymoglobuline in Non-myeloablative Allogeneic Stem-cell Transplantation
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ClinicalTrials.gov Identifier: NCT00130754 |
Recruitment Status :
Completed
First Posted : August 16, 2005
Last Update Posted : February 23, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stem Cell Transplantation Graft Vs Host Disease | Drug: Thymoglobuline | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Prospective Randomized, Controlled Pilot Study in Order to Evaluate the Place of Thymoglobuline in Non-myeloablative Allogeneic Hemapoietic Stem-cell Transplantation (NST) |
Study Start Date : | February 2005 |
Actual Study Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Thymo
|
Drug: Thymoglobuline
IV 7.5 mg/kg |
No Intervention: 2 |
- Acute GVHD occurrence [ Time Frame: 100d ]
- Acute GVHD grading [ Time Frame: 100d ]
- Time to acute GVHD [ Time Frame: 100d ]
- Chronic GVHD occurrence [ Time Frame: 1y ]
- Chronic GVHD grading [ Time Frame: 1y ]
- Engraftment/graft rejection [ Time Frame: 21d ]
- Overall survival [ Time Frame: 1y ]
- Disease free survival [ Time Frame: 1y ]
- Infections [ Time Frame: 1y ]
- Transplant-related mortality (TRM) [ Time Frame: 1y ]
- Transplant-related toxicity (TRT) [ Time Frame: 1y ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients ages 18-75 years old with a disease necessitating allogeneic SCT.
- Patients must have an HLA compatible donor willing and capable of donating peripheral blood stem cells preferably, or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (HLA compatible defined as 5/6 or 6/6 matched related [A, B, DR] or 8/8 molecular [A, B, C, DR] matched unrelated donor).
- Both patients and donor must sign written informed consents.
- Patients must have an ECOG performance status (PS) ≤ 2; Creatinine < 2.0 mg/dl; Ejection fraction > 40%; Diffusing capacity of the lung for carbon monoxide (DLCO) > 50% of predicted; Serum bilirubin < 3 gm/dl; Elevated GPT or GOT > 3 x normal values.
Exclusion Criteria:
- Not fulfilling any of the inclusion criteria
- Active life-threatening infection
- Overt untreated infection
- Hypersensitivity to thymoglobuline or other rabbit produced immunoglobulin.
- HIV seropositivity, hepatitis B or C antigen positivity with active hepatitis
- Pregnant or lactating women.
- Donor contraindication (HIV seropositive confirmed by Western Blot; hepatitis B antigenemia; evidence of bone marrow disease; unable to donate bone marrow or peripheral blood due to concurrent medical condition).
- Inability to comply with study requirements.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130754
Israel | |
Hadassah Medical Organization | |
Jerusalem, Israel, 91120 |
Principal Investigator: | Michael Y Shapira, MD | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00130754 |
Other Study ID Numbers: |
39-14.01.05-HMO-CTIL |
First Posted: | August 16, 2005 Key Record Dates |
Last Update Posted: | February 23, 2011 |
Last Verified: | November 2007 |
Graft vs Host Disease Immune System Diseases Thymoglobulin |
Immunologic Factors Physiological Effects of Drugs Immunosuppressive Agents |