Clinical trial · Interventional

Sirolimus, Tacrolimus, and Antithymocyte Globulin in Preventing Graft-Versus-Host Disease in Patients With Hematologic Cancer Who Are Undergoing Donor Stem Cell Transplant

A Phase II Study of Sirolimus, Tacrolimus and Thymoglobulin®, as Graft-versus-Host- Disease Prophylaxis in Patients Undergoing Unrelated Donor Hematopoietic Cell Transplantation

NCT00691015CI-TRIAL-00028313completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving low doses of chemotherapy, monoclonal antibodies, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus, sirolimus, and antithymocyte globulin before and after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects of giving sirolimus together with tacrolimus and antithymocyte globulin and to see how well it works in preventing graft-versus-host disease in patients with hematologic cancer who are undergoing donor stem cell transplant.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Multiple Myeloma and Plasma Cell Neoplasm	—	UNRESOLVED	—
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (10)

Intervention	Type	Mapped drug	Match
anti-thymocyte globulin IV	Drug	—	UNRESOLVED
busulfan	Drug	Busulfan	ALIAS
carmustine	Drug	Carmustine	ALIAS
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
cytarabine	Drug	Cytarabine	ALIAS
etoposide	Drug	Etoposide	ALIAS
fludarabine phosphate	Drug	Fludarabine	ALIAS
melphalan	Drug	Melphalan	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Chemotherapy or chemotherapy + total body irradiation
description
Standard of care (SOC) chemotherapy or ( SOC) chemotherapy + total body irradiation (TBI) of one of the following regimens: Regimen I: Patients receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen II: Patients undergo total body irradiation (TBI) twice daily for 8 fractions and receive etoposide IV;anti-thymocyte globulin IV. Regimen III: Patients undergo TBI once or twice daily for 11 fractions and receive cyclophosphamide IV; anti-thymocyte globulin IV. Regimen IV: Patients undergo TBI and receive fludarabine phosphate IV and busulfan IV; anti-thymocyte globulin IV. Regimen V: Patients receive carmustine IV, etoposide IV, cytarabine IV, and melphalan IV. Some patients also receive rituximab IV; anti-thymocyte globulin IV. Regimen VI: Patients receive fludarabine phosphate IV and melphalan IV. Some patients also undergo TBI; anti-thymocyte globulin IV.
interventionNames
1. Biological: rituximab
2. Drug: busulfan
3. Drug: carmustine
4. Drug: cyclophosphamide
5. Drug: cytarabine
6. Drug: etoposide
7. Drug: fludarabine phosphate
8. Drug: melphalan
9. Radiation: total body irradiation (TBI)
10. Drug: anti-thymocyte globulin IV

Primary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of a hematological malignancy, including any of the following:

  * Non-Hodgkin lymphoma in complete remission (CR) or partial remission (PR)
  * Hodgkin lymphoma in CR or PR
  * Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) meeting either of the following criteria:

    * In CR
    * Not in CR and meets the following criteria:

      * Bone marrow blast \< 20% within 4 weeks of transplantation
      * Peripheral blood absolute blast count \< 500 per microliter on the day of initiating conditioning therapy
  * Myelodysplastic syndromes, treated or untreated
  * Chronic myeloid leukemia in chronic phase or accelerated phase
  * Multiple myeloma in CR or PR
  * Chronic lymphocytic leukemia in second or greater CR or PR
  * Myelofibrosis or other myeloproliferative disorders meeting the following criteria:

    * Bone marrow blasts \< 20% within 4 weeks of transplantation
    * Peripheral blood absolute blast count \< 500 per microliter on the day of initiating conditioning therapy
    * Patients with ascites not allowed
* No prior bone marrow or ex vivo engineered or processed graft (i.e., CD34+ enrichment, T-cell depletion, etc)
* Scheduled to undergo peripheral blood stem cell transplantation from a suitable HLA-matched or -mismatched unrelated donor, as determined by treating physician

  * High resolution molecular HLA typing is required for HLA class I and II
  * No more than one antigen or allele mismatch
* No documented uncontrolled CNS disease

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-2
* Karnofsky PS 60-100%
* Creatinine clearance \> 50 mL/min
* Bilirubin \< 3 times upper limit of normal (ULN)
* ALT and AST \< 3 times ULN
* LVEF \> 50%
* FVC, FEV\_1, or DLCO \> 50% predicted

  * Patients on home oxygen not allowed
* Able to cooperate with oral medication intake
* HIV negative
* No active hepatitis B or hepatitis C
* No known contraindication to sirolimus, tacrolimus, or anti-thymocyte globulin

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment