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

NCT00104975 | Completed Phase 1

• 3 other identifiers: CDR0000413698YALE-25971NCI-6765
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms

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

Interventions

alemtuzumab BIOLOGICAL

therapeutic allogeneic lymphocytes BIOLOGICAL

fludarabine phosphate DRUG

melphalan DRUG

tacrolimus DRUG

thiotepa DRUG

peripheral blood stem cell transplantation PROCEDURE

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Yale University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Leukemia; Lymphoma; Myelodysplastic Syndromes; Myelodysplastic-Myeloproliferative Diseases; Leukemia, Myeloid, Accelerated Phase; Burkitt Lymphoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large-Cell, Immunoblastic; Anemia, Refractory, with Excess of Blasts; Leukemia, Myelomonocytic, Chronic; Blast Crisis; Pdgfra-Associated Chronic Eosinophilic Leukemia; Primary Myelofibrosis; Leukemia, Neutrophilic, Chronic; Thrombocythemia, Essential; Polycythemia Vera; Congenital Abnormalities; Leukemia, Myeloid, Acute; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative

Interventions

Alemtuzumab; fludarabine phosphate; Melphalan; Tacrolimus; Thiotepa; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Anemia, Refractory; Anemia; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Macrolides; Lactones; Phosphoramides; Organophosphorus Compounds; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Erkut Bahceci, MD

  Yale University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: February 1, 2005
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)