Clinical trial NCT01499147: Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
Official title: Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Acute Leukemia
Chronic Myelogenous Leukemia
Malignant Lymphoma
Hodgkin's Disease
Multiple Myeloma
Lymphocytic Leukemia
Myeloproliferative Disorder
Polycythemia Vera
Myelofibrosis
Aplastic Anemia
Keywords: Acute myeloid leukemia
First remission
Acute lymphocytic leukemia
Acute leukemia
Second remission
Early relapse
Partial remission
Accelerated phase
Blast-crisis
Chronic myelogenous leukemia
Chronic phase
Recurrent malignant lymphoma
Refractory malignant lymphoma
Hodgkin's disease
Multiple myeloma.
Chronic lymphocytic leukemia
Myeloproliferative disorder
Polycythemia vera
Myelofibrosis
Severe aplastic anemia
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2011-12-26
Enrollment: 100
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Participants With Engraftment.
timeFrame: Up to 30 days post-transplant
Secondary outcomes:
measure: Participants With 100 Day Transplant-related Mortality.
timeFrame: Up to 100 days post-transplant.
measure: Time to ANC and Platelet Engraftment
timeFrame: Up to 30 days post-transplant
measure: Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
timeFrame: Up to 100 days post-transplant (acute GVHD).
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Damiano Rondelli, MD
role: PRINCIPAL_INVESTIGATOR
References: