Skip to content
Triangle logo TriangleGet started
← Study library

NCT00943319 · REGISTRY CONDITION SEARCH

Busulfan-fludarabine Conditioning and T-cell Depleted Allogeneic Stem Cell Transplantation for Patients With Advanced Hematologic Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2019-02-04

The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Maximum Tolerated Dose

→

outcome · POSTED

Overall Survival

→

outcome · POSTED

Disease Free Survival

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: Phase I portion: * Relapsed or refractory acute myelogenous or lymphoid leukemia. * Chronic myelogenous leukemia in accelerated phase or blast-crisis. * Recurrent or refractory malignant lymphoma or Hodgkin's disease * Recurrent or refractory multiple myeloma. * Chronic lymphocytic leukemia, relapsed or with poor prognostic features. * Myeloproliferative disorder (polycythemia vera, myelofibrosis) with transformation * Myelodysplastic syndromes with more than 5% blasts. Phase II portion: * AML with active disease or beyond CR2. * MDS with more than 5% blasts. Exclusion Criteria: * Clinical progression. Such patients may be treated on other treatment protocols or at the investigator's discretion. Such patients will continue to be monitored for survival and, may be asked to continue to provide specimens for studies of minimal residual disease and immune reconstitution as other treatments are recommended.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Intravenous busulfan (Busulfan®) in combination with fludarabine
    intervention Names
    1. Drug: Busulfan
    2. Drug: Fludarabine
    3. Drug: Campath
    4. Procedure: Stem Cell Transplant
    label
    Busulfan and fludarabine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Busulfan and fludarabine
    description
    Daily intravenous dosing to target AVC
    name
    Busulfan
    type
    DRUG
  2. arm Group Labels
    1. Busulfan and fludarabine
    description
    Fludarabine dosing will be based on actual body weight. Fludarabine will be infused over 30 minutes before busulfan treatment dose.
    name
    Fludarabine
    type
    DRUG
  3. arm Group Labels
    1. Busulfan and fludarabine
    description
    All patients will receive premedication for Campath (daily doses of 20 mg are repeated for up to five times).
    name
    Campath
    type
    DRUG
  4. arm Group Labels
    1. Busulfan and fludarabine
    description
    Infusion of bone marrow and donors(related/ unrelated).
    name
    Stem Cell Transplant
    type
    PROCEDURE
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
50
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Maximally tolerated area under the curve of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. The number reported will be an Area Under the Curve (AUC) measure reported in µmol-min/L.
    measure
    Maximum Tolerated Dose
    time Frame
    5 years
secondary Outcomes
  1. description
    Overall Survival measured as median survival in days
    measure
    Overall Survival
    time Frame
    5 years
  2. description
    Disease Free Survival measured by median survival time in days
    measure
    Disease Free Survival
    time Frame
    5 years
Full study description
brief Summary
The purpose of this study is: 1. To establish the maximally tolerated dose (MTD) of intravenous busulfan (Busulfan®) in combination with fludarabine as conditioning regimen for transplantation with in-vivo T-cell depletion. 2. To evaluate disease free and overall survival after this conditioning regimen in patients with advanced acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). 3. To evaluate potential pharmacogenomic determinants of toxicity of this regimen. 4. To evaluate potential pharmacogenomic determinants of efficacy of this regimen.
Source references
references
  1. citation
    O'Donnell PH, Artz AS, Undevia SD, Pai RK, Del Cerro P, Horowitz S, Godley LA, Hart J, Innocenti F, Larson RA, Odenike OM, Stock W, Van Besien K. Phase I study of dose-escalated busulfan with fludarabine and alemtuzumab as conditioning for allogeneic hematopoietic stem cell transplant: reduced clearance at high doses and occurrence of late sinusoidal obstruction syndrome/veno-occlusive disease. Leuk Lymphoma. 2010 Dec;51(12):2240-9. doi: 10.3109/10428194.2010.520773. Epub 2010 Oct 4.
    pmid
    20919852
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-ac54386e6a6c8da74c37
      requested nct id
      NCT00943319
      primary nct id
      NCT00943319
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      1d11cb982b5b6df939c7ff00d813bb2074da790cb6c4f223fd5766d99af1d18d
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-ac54386e6a6c8da74c37
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00943319
      occurrences
      1. context exact
        NCT00943319
        end
        11
        exact text
        NCT00943319
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/948/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      51339193a18a8279efe251ee3720bdf96f42a22945bd8be57057b21496a931ad

    Preserved source evidence · Not medical advice