LeukemiaPhase 2NCT01649622
Bendamustine in Acute Lymphoblastic Leukemia/Lymphoma (ALL)
A Phase 2 study testing Bendamustine in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if bendamustine can help to control Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied. Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them to die. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Bendamustine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with relapsed/ refractory lymphoid T-cell or B-cell acute lymphoblastic leukemia which has been previously treated with at least one line of chemotherapy.
- Age >/= 18
- Patients must have adequate organ function including adequate renal function (calculated creatinine clearance >/= 50ml/min calculated per the Cockcroft-Gault formula). Patients must have adequate hepatic function (AST or ALT < 2.5 x ULN and total bilirubin < 3X ULN) for the reference lab unless due to leukemia.
- Patients must have adequate performance status (ECOG 0-3).
- Female patients must not be pregnant or lactating. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment. Female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception.
- Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
- Patients with active CNS involvement of leukemia may be included and treated concurrently with intrathecal chemotherapy if approved by the PI.
Who cannot join
- Patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine or mannitol.
- Patients with untreated or uncontrolled life-threatening infection.
- Patients known to be HIV positive or known to have Hepatitis B and/or C.
- Patients must not have received chemotherapy, monoclonal antibody therapy and/or radiation therapy within 2 weeks of study enrollment unless evidence of rapid disease progression. Hydroxyurea or corticosteroids for control of blood counts is allowed.
- Patients must not have any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
About this study
Official title: Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma
The goal of this clinical research study is to learn if bendamustine can help to control Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.
Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them to die.
Read the detailed description
Study Drug Administration:
Patient will receive bendamustine by vein over 30 minutes twice a day on Days 1-4 of every study cycle. The length of each study cycle will depend on how the disease responds to the study drug. Each cycle will last 3 to 10 weeks.
Study Visits:
Before each cycle, patient will have a physical exam, including measurement of vital signs.
One (1) time each week, blood (about 2 tablespoons) will be drawn for routine tests. These blood draws will no longer be drawn every week if at any point the disease appears to be getting better. After that, this blood will only be drawn every 2-4 weeks while patient is receiving the study drug. These blood draws can be performed by a doctor near the patient and the results will be reported to the study doctor.
On Day 21 of Cycle 1, then every 4 weeks, patient will have a bone marrow aspirate and/or biopsy to check the status of the disease. If patient's doctor thinks it is needed, bone marrow aspirates and/or biopsies may be collected more or less often, depending on the status of the disease.
Length of Treatment:
Patient may receive up to 12 cycles of the study drug. Patient will be taken off study early if the disease gets worse, if intolerable side effects occur, or if the study doctor thinks it is in patient's best interest. Patient's participation in the study will be over after they complete the follow-up visits.
Follow-up Visits:
Patient will be asked to return to the clinic every 3 to 6 months for up to 5 years after they stop receiving the study drug. Patient will be asked about any side effects or symptoms they may be having. If patient is are unable to return to MD Anderson, the follow-up visits may be conducted over the phone. Each call should last about 5 minutes.
Blood (about 2 tablespoons) will also be drawn for routine tests every 4-8 weeks during this follow-up period.
This is an investigational study. Bendamustine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
- Being tested
- Bendamustine
- Keywords
- Leukemia, Lymphoma, Acute Lymphoblastic Leukemia/Lymphoma, ALL, Relapsed or primary refractory B-cell/T-cell, Bendamustine, Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-105, Treanda
- Medical subject headings
- Leukemia, Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BendamustineDrug
Also called Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-105
75 mg/m2 by vein twice daily for four days (Days 1-4). Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | Patients receive Bendamustine at dose of 75 mg/m2 by vein over 30 minutes twice daily for four days (Days 1-4). Bendamustine dose based on actual body weight.
Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses. Receives: Drug: Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Primary endpoint for evaluating efficacy objective response rate (ORR = complete remission (CR), complete response with no recovery of platelet count > 100 k/mm3 (CRp), complete response criteria with no recovery of absolute neutrophil count greater than 1000/mm3 and/or platelet count > 100 k/mm3 (CRi), partial response (PR). Disease-free survival (DFS) time from date of treatment start until date of first objective documentation of disease-relapse. Overall survival (OS) time from date of treatment start until date of death due to any cause or last follow up.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hagop Kantarjian, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01649622
- Sponsor's protocol ID
- 2012-0345
- Status last verified
- Nov 2012
- First submitted
- 23 Jul 2012
- Last updated
- 8 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Bendamustine in Adult Patients With Acute Lymphoblastic Leukemia/Lymphoma
- ClinicalTrials.gov ID
- NCT01649622
- Acronym / sponsor ID
- 2012-0345
- Keywords
- Leukemia, Lymphoma, Acute Lymphoblastic Leukemia/Lymphoma, ALL, Relapsed or primary refractory B-cell/T-cell, Bendamustine, Bendamustine Hydrochloride, Bendamustine HCL
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2018 (estimated)
- First posted
- 25 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn if bendamustine can help to control Acute Lymphoblastic Leukemia/Lymphoma (ALL). The safety of this drug will also be studied.
Bendamustine is designed to damage and destroy the DNA of cancer cells, which may cause them to die.
Detailed description
Study Drug Administration:
Patient will receive bendamustine by vein over 30 minutes twice a day on Days 1-4 of every study cycle. The length of each study cycle will depend on how the disease responds to the study drug. Each cycle will last 3 to 10 weeks.
Study Visits:
Before each cycle, patient will have a physical exam, including measurement of vital signs.
One (1) time each week, blood (about 2 tablespoons) will be drawn for routine tests. These blood draws will no longer be drawn every week if at any point the disease appears to be getting better. After that, this blood will only be drawn every 2-4 weeks while patient is receiving the study drug. These blood draws can be performed by a doctor near the patient and the results will be reported to the study doctor.
On Day 21 of Cycle 1, then every 4 weeks, patient will have a bone marrow aspirate and/or biopsy to check the status of the disease. If patient's doctor thinks it is needed, bone marrow aspirates and/or biopsies may be collected more or less often, depending on the status of the disease.
Length of Treatment:
Patient may receive up to 12 cycles of the study drug. Patient will be taken off study early if the disease gets worse, if intolerable side effects occur, or if the study doctor thinks it is in patient's best interest. Patient's participation in the study will be over after they complete the follow-up visits.
Follow-up Visits:
Patient will be asked to return to the clinic every 3 to 6 months for up to 5 years after they stop receiving the study drug. Patient will be asked about any side effects or symptoms they may be having. If patient is are unable to return to MD Anderson, the follow-up visits may be conducted over the phone. Each call should last about 5 minutes.
Blood (about 2 tablespoons) will also be drawn for routine tests every 4-8 weeks during this follow-up period.
This is an investigational study. Bendamustine is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL) and B-cell non-Hodgkin's lymphoma.
Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: BendamustinePatients receive Bendamustine at dose of 75 mg/m2 by vein over 30 minutes twice daily for four days (Days 1-4). Bendamustine dose based on actual body weight. Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with relapsed/ refractory lymphoid T-cell or B-cell acute lymphoblastic leukemia which has been previously treated with at least one line of chemotherapy.
- Age >/= 18
- Patients must have adequate organ function including adequate renal function (calculated creatinine clearance >/= 50ml/min calculated per the Cockcroft-Gault formula). Patients must have adequate hepatic function (AST or ALT < 2.5 x ULN and total bilirubin < 3X ULN) for the reference lab unless due to leukemia.
- Patients must have adequate performance status (ECOG 0-3).
- Female patients must not be pregnant or lactating. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to study enrollment. Female patients of childbearing potential (including those <1 year postmenopausal) and male patients must agree to use contraception.
Key exclusion criteria (5 listed)
- Patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine or mannitol.
- Patients with untreated or uncontrolled life-threatening infection.
- Patients known to be HIV positive or known to have Hepatitis B and/or C.
- Patients must not have received chemotherapy, monoclonal antibody therapy and/or radiation therapy within 2 weeks of study enrollment unless evidence of rapid disease progression. Hydroxyurea or corticosteroids for control of blood counts is allowed.
- Patients must not have any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to give informed consent or cooperate and participate in the study or interfere with the interpretation of the results.
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 |
|---|---|---|
| BendamustineAlso: Bendamustine Hydrochloride, Bendamustine HCL, CEP-18083, SDX-10575 mg/m2 by vein twice daily for four days (Days 1-4). Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses. | Drug | Bendamustine |
Primary outcome
Overall Response Rate (ORR)
Time frame: 21 days
Primary endpoint for evaluating efficacy objective response rate (ORR = complete remission (CR), complete response with no recovery of platelet count > 100 k/mm3 (CRp), complete response criteria with no recovery of absolute neutrophil count greater than 1000/mm3 and/or platelet count > 100 k/mm3 (CRi), partial response (PR). Disease-free survival (DFS) time from date of treatment start until date of first objective documentation of disease-relapse. Overall survival (OS) time from date of treatment start until date of death due to any cause or last follow up.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Hagop Kantarjian, MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bendamustine in people with Leukemia and Lymphoma, run by M.D. Anderson Cancer Center.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 8 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall Response Rate (ORR) (time frame: 21 days). 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 2012.