NCT00002534

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Randomized phase III trial to compare the effectiveness of bone marrow transplantation using untreated or treated bone marrow in treating patients with acute leukemia in first or second remission.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 1993

Longer than P75 for phase_3 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1993

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

9.9 years

First QC Date

November 1, 1999

Last Update Submit

June 24, 2013

Conditions

Leukemia

Keywords

recurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiarecurrent adult acute myeloid leukemiarecurrent adult acute lymphoblastic leukemiaadult acute myeloid leukemia in remissionadult acute lymphoblastic leukemia in remissionchildhood acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionacute undifferentiated leukemia

Interventions

anti-thymocyte globulinBIOLOGICAL
cyclophosphamideDRUG
cytarabineDRUG
methylprednisoloneDRUG
thiotepaDRUG
allogeneic bone marrow transplantationPROCEDURE
in vitro-treated bone marrow transplantationPROCEDURE
low-LET electron therapyRADIATION
low-LET photon therapyRADIATION

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Acute leukemias in the following categories: Histologically documented ANLL in first remission (CR1) or second remission (CR2) Pediatric ANLL patients in CR1 eligible provided they are not enrolled on protocol CCG-2891 ALL in CR1 presenting with at least 1 of the following high-risk features: WBC at presentation greater than 50,000/mm3 (200,000/mm3 in pediatric patients) Hypoploidy as measured by flow cytometry Pseudodiploidy with translocations t(9;22), t(4;11), and t(8;14) CR not achieved until after 4 weeks of induction therapy ALL in CR2 that has relapsed in the bone marrow following a first remission regardless of time of relapse Acute biphenotypic leukemia (mixed myeloid and lymphoid lineage at presentation) in CR1 or CR2, i.e., patients classified as lymphoblastic or myeloblastic based on FAB morphology and histochemistry features Adult acute undifferentiated leukemia (no evidence of lymphoid or myeloid differentiation) and in CR1 or CR2 Patients in this category are analyzed separately CR defined as no evidence of leukemia at time of transplantation as documented by normocellular bone marrow aspirate containing no more than 5% blasts no more than 2 weeks prior to cytoreduction Normal diagnostic LP or Ommaya reservoir tap required no more than 2 weeks prior to start of cytoreduction in all ALL patients and in ANLL patients at risk for CNS disease No extramedullary disease at time of transplantation HLA-identical, MLC-compatible related donor required Donor must be healthy and willing to undergo general anesthesia and donation procedure For T-cell depletion, donor should be able to have a volume of 15 ml/kg patient body weight harvested safely PATIENT CHARACTERISTICS: Age: Any age (5 to 55 to be eligible for randomization) Performance status: Karnofsky (or Lansky) 70-100% Life expectancy: Greater than 8 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dl SGOT no greater than 3 times upper limit of normal (ULN) (both parameters stable for at least 4 weeks prior to transplantation) Renal: Creatinine less than 2 times ULN and stable for at least 4 weeks prior to transplantation OR Creatinine clearance at least 70 mL/min Cardiovascular: Fractional shortening greater than 28% on echocardiogram (23-28% if FS increases as a response to stress on supine bicycle ergometer) LVEF at least 50% on echocardiogram or MUGA Other: In good clinical condition at time of transplantation with no medical problems that would significantly increase the risk of the procedure No infection at time of transplantation Not pregnant or nursing PRIOR CONCURRENT THERAPY: See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Biphenotypic, Acute

Interventions

Antilymphocyte SerumCyclophosphamideCytarabineMethylprednisoloneThiotepa

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex MixturesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTriethylenephosphoramideAziridinesAzirines

Study Officials

  • Farid Boulad, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

May 1, 1993

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

US(1)