Acute Myeloid LeukemiaNCT01499147
Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
A study testing fludarabine/busulfan, fludarabine/ melphalan and ATG in people with Acute Myeloid Leukemia and Acute Leukemia, run by University of Illinois at Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia
- What is being tested?
- fludarabine/busulfan, fludarabine/ melphalan and ATG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to May 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Being tested
- fludarabine/busulfan, fludarabine/ melphalan, ATG
- 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
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Lymphoma, Hodgkin Disease, Multiple Myeloma, Leukemia, Lymphoid, Myeloproliferative Disorders, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fludarabine/busulfanDrug
Also called Fludarabine:, Fludarabine Phosphate, Fludara, Busulfan:
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.
fludarabine/ melphalanDrug
Also called Fludarabine:, Fludarabine phosphate, Fludara, Melphalan:
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).
ATGDrug
Also called Thymoglobulin
Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. Receives: Drug: fludarabine/busulfan; Drug: ATG |
| Arm 2 | Active comparator | All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. Receives: Drug: fludarabine/ melphalan; Drug: ATG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Engraftment.
Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
Measured: Up to 30 days post-transplant
Secondary outcomes (3)
Participants With 100 Day Transplant-related Mortality.
Day 100 transplant-related mortality was measured in both groups.
Measured: Up to 100 days post-transplant.
Time to ANC and Platelet Engraftment
Days to ANC or platelet engraftment
Measured: Up to 30 days post-transplant
Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).
Acute GVHD grade 2-4 was assessed in patients in the FluBU and FluMel groups up to 100 days after transplant.
Measured: Up to 100 days post-transplant (acute GVHD).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startFeb 2000
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damiano Rondelli, MD, University of Illinois at Chicago
- Investigators
- Damiano Rondelli, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499147
- Sponsor's protocol ID
- 2000-0117
- Status last verified
- Oct 2018
- First submitted
- 23 Nov 2011
- Last updated
- 8 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT01499147
- Acronym / sponsor ID
- 2000-0117
- Conditions
- Acute Myeloid Leukemia, Acute Leukemia, Chronic Myelogenous Leukemia, Malignant Lymphoma, Hodgkin's Disease, Multiple Myeloma
- Keywords
- Acute myeloid leukemia, First remission, Acute lymphocytic leukemia, Acute leukemia, Second remission, Early relapse, Partial remission, Accelerated phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- Feb 2000
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: fludarabine/busulfan, Drug: ATGAll patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor. |
| Arm 2 | Active comparator | Drug: fludarabine/ melphalan, Drug: ATGAll patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG. |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Patients with the following diseases:
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fludarabine/busulfanAlso: Fludarabine:, Fludarabine Phosphate, Fludara, Busulfan: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. | Drug | Arm 1 |
| fludarabine/ melphalanAlso: Fludarabine:, Fludarabine phosphate, Fludara, Melphalan: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). | Drug | Arm 2 |
| ATGAlso: ThymoglobulinPatients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen. | Drug | Arm 1, Arm 2 |
Primary outcome
Number of Participants With Engraftment.
Time frame: Up to 30 days post-transplant
Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
3 secondary outcomes
Participants With 100 Day Transplant-related Mortality.
Time frame: Up to 100 days post-transplant.
Time to ANC and Platelet Engraftment
Time frame: Up to 30 days post-transplant
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damiano Rondelli, MD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fludarabine/busulfan, fludarabine/ melphalan and ATG in people with Acute Myeloid Leukemia and Acute Leukemia, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Engraftment. (time frame: Up to 30 days post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.