Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia in Remission

NCT00101140 | Withdrawn Phase 2

• 2 other identifiers: CDR0000405838ECOG-E1903
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy or radiation therapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving total-body irradiation together with fludarabine, thiotepa, and antithymocyte globulin before transplant may stop this from happening. PURPOSE: This phase II trial is studying how well a donor stem cell transplant works in treating patients with acute myeloid leukemia in remission.

Conditions

Adult Acute Erythroid Leukemia; Adult Acute Monoblastic and Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia

Keywords

adult erythroleukemia (M6a); adult acute megakaryoblastic leukemia (M7); adult acute minimally differentiated myeloid leukemia (M0); adult acute monocytic leukemia (M5b); adult acute myeloblastic leukemia with maturation (M2); adult acute myeloblastic leukemia without maturation (M1); 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(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myelomonocytic leukemia (M4)

Interventions

anti-thymocyte globulin DRUG

fludarabine phosphate DRUG

thiotepa DRUG

biological therapy PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

chemotherapy PROCEDURE

non-specific immune-modulator therapy PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

radiation therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Morphologically confirmed acute myeloid leukemia of 1 of the following subtypes: * Acute myeloblastic leukemia (M0, M1, M2) * Acute myelomonocytic leukemia (M4) * Acute monocytic leukemia (M5) * Acute erythroleukemia (M6) * Acute megakaryocytic leukemia (M7) * Must have 1 of the following karyotypic abnormalities at the time of diagnosis: * Complex cytogenetic abnormalities (≥ 3 cytogenetic clones) * Abnormalities of chromosome 5 \[-5 or del(5q)\] * Abnormalities of the long (q) arm of chromosome 3, 9, 11, 20, or 21 * Abnormalities of the short (p) arm of chromosome 17, monosomy 7, t(9;22), or t(6;9) (8) * In morphologic first complete remission\*, as evidenced by all of the following for ≥ 4 weeks before study entry: * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Leukemic blasts not present in the peripheral blood * Cellularity of bone marrow biopsy \> 20% with maturation of all cell lines * Less than 5% blasts by bone marrow biopsy * No extramedullary leukemia, such as CNS or soft tissue involvement NOTE: \*Reduced hemoglobin concentration or hematocrit has no bearing on remission status * Haploidentical (3/6 or 4/6 antigen matched \[A, B, and DR\]) family donor available PATIENT CHARACTERISTICS: Age * 18 to 59 Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * See Disease Characteristics Hepatic * Bilirubin ≤ 2.0 mg/dL * AST \< 2 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Cardiovascular * Ejection fraction \> 40% by MUGA or echocardiogram * None of the following within the past 3 months: * Myocardial infarction * Significant congestive heart failure * Significant cardiac arrhythmia Pulmonary * FEV\_1 and DLCO \> 50% of predicted Immunologic * HIV negative * No active or unresolved infection * No evidence of invasive fungal infection (e.g., positive blood or deep tissue cultures or stains) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No organ damage * No other medical problem that would preclude study participation * No other currently active tumor that would likely interfere with study treatment or that would likely compromise the patient's morbidity or mortality PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent routine use of filgrastim (G-CSF) or sargramostim (GM-CSF) to accelerate hematopoietic recovery post-transplantation Chemotherapy * More than 4 weeks since prior chemotherapy Endocrine therapy * Not specified Radiotherapy * More than 4 weeks since prior radiotherapy Surgery * Not specified

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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Leukemia, Erythroblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Leukemia, Megakaryoblastic, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute

Interventions

Antilymphocyte Serum; fludarabine phosphate; Thiotepa; Biological Therapy; Drug Therapy; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Transplantation; Surgical Procedures, Operative

Study Officials

• Mark R. Litzow, MD

  Mayo Clinic

  STUDY CHAIR

• Jacob M. Rowe, MD

  Rambam Health Care Campus

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: January 7, 2005
• First Posted: January 10, 2005
• Last Updated: October 19, 2017

Record last verified: 2017-10