Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies (NCT01499147) | Clinical Trial Compass
CompletedNot Applicable
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
United States100 participantsStarted 2000-02
Plain-language 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.
Who can participate
Age range
10 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.