Clinical trial · Interventional
Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis
NCT00133367CI-TRIAL-00023220completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Myelogenous Leukemia | Myeloid Leukemia | ALIAS | 0.90 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antithymocyte globulin | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Melphalan | Drug | Melphalan | ALIAS |
| Sirolimus | Drug | Sirolimus | ALIAS |
| Tacrolimus | Drug | — | UNRESOLVED |
| Thymoglobulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To determine the effectiveness of tacrolimus and sirolimus in preventing graft versus host disease
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- To evaluate the days to neutrophil engraftment and platelet engraftment
- timeFrame
- 2 years
- measure
- To evaluate the relapse rate and overall disease free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with hematologic malignancies for whom allogeneic stem cell transplantation is deemed clinically appropriate * Non-Hodgkin's lymphoma, or Hodgkin's lymphoma: in Complete Remission \>2 (second complete remission, third complete remission, etc) or in partial remission * Multiple myeloma: relapsed * Chronic lymphocytic leukemia, Rai stage III or IV, or lymphocyte doubling time of 6 months, or stage I-II, having progressed after \> 2 chemotherapy regimens, in partial remission. * Acute myelogenous or lymphoblastic leukemia in second or subsequent remission or in first remission with adverse cytogenetic or antecedent hematologic disorder * Chronic myelogenous leukemia in accelerated or second stable phase, or imatinib resistant and not eligible for an ablative transplant * Myelodysplasia, previously treated or not eligible for ablative transplant * Age 18-65 years. * ECOG performance status of 0, 1, or 2. * Lack of 6/6 or 5/6 HLA-matched related, 10/10 matched unrelated donor, or unrelated donor not available within the time frame necessary to perform a potentially curative stem cell transplant. Exclusion Criteria: * Cardiac disease: * symptomatic congestive heart failure or * radionuclide ventriculogram (RVG) or echocardiogram determined left ventricular ejection fraction of \< 40%, * active angina pectoris, or * uncontrolled hypertension. * Pulmonary disease: * severe chronic obstructive lung disease, or * symptomatic restrictive lung disease, or * corrected DLCO of \< 50% of predicted. * Renal disease: * serum creatinine \> 2.0 mg/dl. * Hepatic disease: * serum bilirubin \> 2.0 mg/dl (except in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be elevated greater than 2.0mg/dl), * SGOT or SGPT \> 3 x normal. * Neurologic disease: * symptomatic leukoencephalopathy, * active central nervous system (CNS) malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (previous CNS malignancy, presently in complete remission \[CR\] is not exclusion). * HIV antibody. * Uncontrolled infection. * Pregnancy or breast feeding mother.
References
Publications (1)
- DERIVEDBrown JA, Stevenson K, Kim HT, Cutler C, Ballen K, McDonough S, Reynolds C, Herrera M, Liney D, Ho V, Kao G, Armand P, Koreth J, Alyea E, McAfee S, Attar E, Dey B, Spitzer T, Soiffer R, Ritz J, Antin JH, Boussiotis VA. Clearance of CMV viremia and survival after double umbilical cord blood transplantation in adults depends on reconstitution of thymopoiesis. Blood. 2010 May 20;115(20):4111-9. doi: 10.1182/blood-2009-09-244145. Epub 2010 Jan 27. PMID 20107229