Clinical trial · Interventional

Alemtuzumab and Combination Chemotherapy Followed By Donor Lymphocytes in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Reduced Intensity Conditioning Regimen for Haplo-identical Family Donor Stem Cell Transplants for Hematologic Malignancies With Delayed Add-back of Non-alloreactive T Cells

NCT00104975CI-TRIAL-00025155completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Giving low doses of chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells that have been treated in the laboratory after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving tacrolimus before and after transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor lymphocytes when given after alemtuzumab and combination chemotherapy in treating patients who are undergoing donor stem cell transplant for hematologic cancer.

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
Chronic Myeloproliferative Disorders	Myeloproliferative Neoplasm	ALIAS	0.90
Leukemia	Leukemia	ONTOLOGY_EXACT	0.90
Lymphoma	Lymphoma	ONTOLOGY_EXACT	0.90
Myelodysplastic/Myeloproliferative Neoplasms	Myelodysplastic/Myeloproliferative Neoplasm	CURATED_BROADER	0.80
Myelodysplastic Syndromes	Myelodysplastic Syndrome	ALIAS	0.90

Interventions

Interventions (7)

Intervention	Type	Mapped drug	Match
alemtuzumab	Biological	Alemtuzumab	ALIAS
fludarabine phosphate	Drug	Fludarabine	ALIAS
melphalan	Drug	Melphalan	ALIAS
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
tacrolimus	Drug	—	UNRESOLVED
therapeutic allogeneic lymphocytes	Biological	—	UNRESOLVED
thiotepa	Drug	Thiotepa	ALIAS

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 55 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Diagnosis of 1 of the following hematologic malignancies:

  * Chronic myelogenous leukemia

    * Accelerated phase or blast phase
  * Acute myeloid leukemia, meeting any of the following criteria:

    * In second or subsequent remission
    * In primary induction failure
    * In partial remission
    * In resistant relapse
  * Chronic lymphocytic leukemia

    * In Richter's transformation
  * High-grade non-Hodgkin's lymphoma

    * Refractory to standard treatment
  * Myeloproliferative disorders

    * Undergoing transformation to terminal stages
  * Myelodysplastic syndromes (MDS), including any of the following:

    * Refractory anemia with excess blasts
    * Transformation to acute leukemia
    * MDS secondary to chemotherapy
* Partially-matched related family donor available

  * One HLA haplotype match
* No HLA-matched (10/10 or 9/10) sibling donor or unrelated donor available NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.

PATIENT CHARACTERISTICS:

Age

* 18 to 55

Performance status

* ECOG 0-1

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* SGOT and SGPT \< 3 times upper limit of normal (ULN)
* No active or persistent viral hepatitis

Renal

* Creatinine \< 2.0 mg/dL\* OR
* Creatinine clearance \> 60 mL/min\* NOTE: \*Unless due to malignancy

Cardiovascular

* LVEF ≥ 45%

Pulmonary

* DLCO ≥ 60% of predicted\* (corrected for hemoglobin) NOTE: \*Unless patient is given clearance by a pulmonary consultation

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for up to 2 years after completion of study treatment
* HIV negative
* Human T cell lymphotrophic virus type 1 negative
* No serious co-morbid medical condition
* No other medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

* Not specified

Chemotherapy

* Not specified

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Feb 1, 2005
Primary completion: May 1, 2008
Completion: May 1, 2008
First posted: Mar 4, 2005
Last update posted: Dec 15, 2016
Enrollment: 20 (estimated)
Lead sponsor: Yale University OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: accelerated phase chronic myelogenous leukemia, recurrent adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, recurrent adult immunoblastic large cell lymphoma, stage IV adult immunoblastic large cell lymphoma, refractory anemia with excess blasts in transformation, refractory anemia with excess blasts, secondary myelodysplastic syndromes, chronic myelomonocytic leukemia, blastic phase chronic myelogenous leukemia, chronic eosinophilic leukemia, primary myelofibrosis, chronic neutrophilic leukemia, essential thrombocythemia, polycythemia vera, adult acute myeloid leukemia in remission, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, refractory chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia, stage III adult Burkitt lymphoma, stage III adult immunoblastic large cell lymphoma, stage III adult lymphoblastic lymphoma, myelodysplastic/myeloproliferative neoplasm, unclassifiable, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, atypical chronic myeloid leukemia, BCR-ABL1 negative

Brief summary (as posted)

Conditions (5)

Interventions (7)

Eligibility (as posted)

Publications (0)

Locations by country (1)