Skip to content
Triangle logo TriangleGet started
← Study library

NCT01499147 · REGISTRY CONDITION SEARCH

Fludarabine Based Conditioning for Allogeneic Transplantation for 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
NA
Status at capture
COMPLETED
Registry last update
2018-11-08

New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.

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

Number of Participants With Engraftment.

→

outcome · POSTED

Participants With 100 Day Transplant-related Mortality.

→

outcome · POSTED

Time to ANC and Platelet Engraftment

→

outcome · POSTED

Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Patients with the following diseases: * Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence. * Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission. * Chronic myelogenous leukemia in accelerated phase or blast-crisis. * Chronic myelogenous leukemia in chronic phase * Recurrent or refractory malignant lymphoma or Hodgkin's disease * Multiple myeloma. * Chronic lymphocytic leukemia, relapsed or with poor prognostic features. * Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features. * Severe aplastic anemia after failure of immunosuppressive therapy. * Age 10-65 years. * Zubrod performance status less than or equal to 2. * Adequate cardiac and pulmonary function. Patients with decreased LVEF \< 40% or DLCO \< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol. * Patient or guardian able to sign informed consent. Exclusion Criteria: * Life expectancy is severely limited by concomitant illness. * Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min . * Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal * Evidence of chronic active hepatitis or cirrhosis * HIV-positive * Patient is pregnant
healthy Volunteers
false
maximum Age
65 Years
minimum Age
10 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
    intervention Names
    1. Drug: fludarabine/busulfan
    2. Drug: ATG
    label
    Arm 1
    type
    ACTIVE_COMPARATOR
  2. description
    All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
    intervention Names
    1. Drug: fludarabine/ melphalan
    2. Drug: ATG
    label
    Arm 2
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm 1
    description
    All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
    name
    fludarabine/busulfan
    other Names
    1. Fludarabine:
    2. Fludarabine Phosphate
    3. Fludara
    4. Busulfan:
    5. Busulfex
    6. Myleran
    type
    DRUG
  2. arm Group Labels
    1. Arm 2
    description
    All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 \<40%, DLCO\<50%, LVEF\<40, Serum bilirubin \>1.5 mg% or serum transaminases \> 2x nl).
    name
    fludarabine/ melphalan
    other Names
    1. Fludarabine:
    2. Fludarabine phosphate
    3. Fludara
    4. Melphalan:
    5. Alkeran
    type
    DRUG
  3. arm Group Labels
    1. Arm 1
    2. Arm 2
    description
    Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
    name
    ATG
    other Names
    1. Thymoglobulin
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
100
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
    measure
    Number of Participants With Engraftment.
    time Frame
    Up to 30 days post-transplant
secondary Outcomes
  1. description
    Day 100 transplant-related mortality was measured in both groups.
    measure
    Participants With 100 Day Transplant-related Mortality.
    time Frame
    Up to 100 days post-transplant.
  2. description
    Days to ANC or platelet engraftment
    measure
    Time to ANC and Platelet Engraftment
    time Frame
    Up to 30 days post-transplant
  3. description
    Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
    measure
    Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
    time Frame
    Up to 100 days post-transplant (acute GVHD).
Full study description
brief Summary
New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
detailed Description
Treatment-related mortality and recurrence of disease account for the majority of treatment failures in allogeneic transplantation for advanced hematologic malignancies. The most commonly utilized conditioning regimens consist of cyclophosphamide and total-body irradiation or busulfan and cyclophosphamide. Other agents such as etoposide or thiotepa are sometimes added to maximize the antileukemic effect. New conditioning regimens are however still needed to maximize efficacy and limit treatment-related deaths. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-601d81da9dcbf9e882b4
      requested nct id
      NCT01499147
      primary nct id
      NCT01499147
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      0c3a3a7013e68f5aa57e59b4b3f45bb1bdf8e95b695c51ab00c3276ae219e941
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-601d81da9dcbf9e882b4
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01499147
      occurrences
      1. context exact
        NCT01499147
        end
        11
        exact text
        NCT01499147
        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/390/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      d291cb3a8a5474e2f6a719785586b9c2a137ad76624b6adc4e56af72658bf089

    Preserved source evidence · Not medical advice