NCT00253513

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as treosulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving treosulfan and fludarabine together with a donor bone marrow transplant or a peripheral stem cell transplant may be an effective treatment for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. PURPOSE: This phase II trial is studying giving treosulfan together with fludarabine to see how well it works in treating patients who are undergoing a donor stem cell transplant for acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1 leukemia

Timeline
Completed

Started Jun 2005

Typical duration for phase_1 leukemia

Geographic Reach
1 country

3 active sites

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

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 11, 2011

Completed
Last Updated

June 1, 2012

Status Verified

February 1, 2011

Enrollment Period

4.3 years

First QC Date

November 11, 2005

Results QC Date

November 16, 2010

Last Update Submit

May 24, 2012

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

adult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionchildhood acute lymphoblastic leukemia in remissionrecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarecurrent childhood acute lymphoblastic leukemiarecurrent childhood acute myeloid leukemiasecondary acute myeloid leukemiamyelodysplastic syndromeschildhood myelodysplastic syndromes

Outcome Measures

Primary Outcomes (3)

  • Number of Patients Experiencing Regimen-related Toxicity Events in Study Population

    Proportion of patients experiencing regimen-related toxicity to major organ systems from day minus 6 to day 28. Major organ systems: cardiac, bladder/renal, pulmonary, hepatic, neurologic and gastrointestinal

    34 days and 2 years

  • Number of Patients Experiencing Graft Failure

    Graft versus Host Disease (GVHD) is a frequent complication of allogeneic bone marrow transplant in which the engrafted donor cells attacks the patient's organs and tissue. Acute GVHD (aGVHD) usually occurs during the first three months following an allogeneic BMT. Chronic GVHD (cGVHD) usually develops after the third month post-transplant. Patients may experience one, both or neither.

    42 days

  • Incidence (Percent of Participants) With Nonrelapse Mortality (NRM) by Day 200 (Secondary Phase Only)

    NRM (Non relapse mortality) - death not attributed to the primary cancer.

    200 days

Secondary Outcomes (1)

  • Number of Subjects Who Are Without Disease at One Year as Indicator of Disease Free Survival.

    One year

Interventions

fludarabineDRUG

30 mg/m2, IV for 5 days

treosulfanDRUG

12 or 14 g/m2, IV for 5 days

allogeneic blood or bone marrow transplantationPROCEDURE

bone marrow or peripheral blood stem cells

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia, lymphoblastic leukemia, or myelodysplastic syndrome * Any phase allowed, including any of the following: * Disease in remission * Relapsed or primary refractory disease * No CNS leukemic involvement not clearing with prior intrathecal chemotherapy and/or cranial radiotherapy * Planning to undergo unmanipulated allogeneic bone marrow or peripheral blood stem cell transplantation * Filgrastim (G-CSF) mobilization of bone marrow or stem cells allowed * Donor available, meeting 1 of the following criteria: * HLA-identical related donor * HLA-A, -B, -C, -DRB1, and -DQB1 matched unrelated donor by high-resolution DNA typing * A single allele mismatch allowed PATIENT CHARACTERISTICS: Performance status * Karnofsky 70-100% OR * Lansky 70-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 2 times upper limit of normal (ULN) * AST ≤ 2 times ULN * No evidence of synthetic dysfunction * No severe cirrhosis * No active infectious hepatitis Renal * Creatinine clearance ≥ 50% * Creatinine ≤ 2 times ULN * Dialysis independent Cardiovascular * No cardiac insufficiency requiring treatment * No symptomatic coronary artery disease * Ejection fraction ≥ 35% (for patients with history of cardiac disease or anthracycline exposure) Pulmonary * PO\_2 ≥ 70 mm Hg AND DLCO ≥ 70% of predicted OR * PO\_2 ≥ 80 mm Hg AND DLCO ≥ 60% of predicted * Not requiring supplementary continuous oxygen Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other disease that would severely limit life expectancy * No HIV positivity * No active infection requiring deferral of conditioning * No known hypersensitivity to the study drugs PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior allogeneic bone marrow or stem cell transplantation * No concurrent umbilical cord blood or autologous transplantation Chemotherapy * See Disease Characteristics Radiotherapy * See Disease Characteristics Other * More than 4 weeks since prior experimental drugs * Concurrent enrollment on another protocol for graft-versus-host disease prophylaxis allowed

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

Sponsors & Collaborators

Study Sites (3)

OHSU Knight Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

fludarabinetreosulfanBone Marrow Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Results Point of Contact

Title
Eneida Nemecek, MD
Organization
OHSU Knight Cancer Institute
nemeceke@ohsu.edu
(503) 494-0829

Study Officials

  • Eneida Nemecek, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

June 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 1, 2012

Results First Posted

February 11, 2011

Record last verified: 2011-02

Locations

US(3)