DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

Information source: University of Illinois at Chicago
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Myeloid Leukemia; Acute Leukemia; Chronic Myelogenous Leukemia; Malignant Lymphoma; Hodgkin's Disease; Multiple Myeloma; Lymphocytic Leukemia; Myeloproliferative Disorder; Polycythemia Vera; Myelofibrosis; Aplastic Anemia

Intervention: fludarabine/busulfan (Drug); fludarabine/ melphalan (Drug)

Phase: N/A

Status: Completed

Sponsored by: University of Illinois at Chicago

Official(s) and/or principal investigator(s):
Damiano Rondelli, MD, Principal Investigator, Affiliation: University of Illinois at Chicago

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.

Clinical Details

Official title: Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To determine the rate of engraftment.

Secondary outcome:

To determine the rate of moderate to severe (grade 2-4) acute and chronic graft versus host disease (GVHD).

To determine the 100 day transplant-related mortality.

To determine the rate of engraftment.

To determine the rate of moderate to severe (grade 2-4) acute and chronic graft versus host disease (GVHD).

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

Minimum age: 10 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

University of Illinois at Chicago Medical Center, Chicago, Illinois 60612, United States
Additional Information

Starting date: February 2000
Last updated: March 27, 2014

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017