Hematologic MalignancyPhase 2NCT02718755
Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies
A Phase 2 study testing Fludarabine, Cytarabine and Erwinase in people with Hematologic Malignancy, run by M.D. Anderson Cancer Center.
Trial summary
The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Fludarabine, Cytarabine and Erwinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2018to May 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a diagnosis of relapsed or refractory hematologic malignancy including, but not limited to Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), Burkitt's leukemia/lymphoma, Prolymphocytic leukemia, Biphenotypic acute leukemia, Blast-phase of chronic myeloid leukemia (CML), B-cell lymphoma, or Richter's transformation of chronic lymphocytic leukemia (CLL)
- Age </= 60 years.
- Adequate organ function as defined below: liver function (bilirubin < 2mg/dL, AST and/or ALT <2.5 x upper limits of normal (ULN)), kidney function (creatinine < 1.5 x ULN ), known cardiac ejection fraction of > or = 45% within the past 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- 5) A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
- 6) Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
- 7) Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.
Who cannot join
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient with documented hypersensitivity to any of the components of the chemotherapy program.
- Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
- Patients with history of clinically significant venous thromboembolism.
About this study
The goal of this clinical research study is to learn if fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied.
Read the detailed description
Study Drug Administration:
Each cycle is 28 days.
If participant is found to be eligible to take part in this study, they will receive treatment in 2 phases: Induction and Consolidation.
All participants will receive the same dose level of fludarabine, cytarabine, and erwinase. If the doctor thinks it is needed, the study drug doses may be reduced.
Induction Phase:
Participant will receive 1-2 cycles during the Induction phase.
On Days 1-5, participant will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours.
On Days 1-7, participant will receive erwinase by vein over about 2 hours or as an injection into the muscle.
If the disease does not respond during Cycle 1, participant may be allowed to receive an additional Induction cycle. If the disease does respond to Induction, participant can move to the Consolidation phase.
Consolidation Phase:
Participant will receive up to 3 cycles during the Consolidation phase.
On Days 1-4, participant will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours. If the doctor thinks it is needed, this may be reduced to Days 1-3.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant will receive erwinase by vein over about 2 hours or as an injection into the muscle.
Study Visits:
On Day 1 (± 3 days) of every cycle, participant will have a physical exam.
Induction Cycle(s):
Every week, blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 1, 8, 9, and 12 of Cycle 1:
- Blood (about 1-2 teaspoons) will be drawn for routine, biomarker, and pharmacodynamic (PD) testing. Biomarkers are found in the blood/tissue and may be related to how the leukemia reacts to the study drug. PD testing measures how the level of study drug in participant's body may affect the disease.
- On Days 9 and 12 only, blood (about 1-2 teaspoons) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
On Day 7 of Cycle 1, blood (about 1-2 teaspoons each time) will be drawn for PK testing before the dose and then 8 more times over the next 24 hours after the dose. Some of these blood samples will also be used for antibody testing. Antibodies are created by the immune system and may attack foreign cells or substances, such as the study drug.
On Day 21 of Cycle 1, participant will have a bone marrow aspiration/biopsy for biomarker and PD testing and to check the status of the disease. If the doctor thinks it is needed, participant may have additional bone marrow aspirations/biopsies while on study.
If participant has a second Induction Cycle and the doctor thinks it is needed, they will have a bone marrow aspirate/biopsy at the end of the second Induction Cycle for biomarker and PD testing and to check the status of the disease.
Consolidation Cycles:
Every 1-2 weeks, blood (about 2-3 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 1, blood (about 1-2 teaspoons) will be drawn for PK testing before the dose and then 8 more times over the next 24 hours after the dose. Some of this blood sample will also be used for antibody testing.
If participant did not have 2 induction cycles, at the end of Cycle 1 of Consolidation, if the doctor thinks it is needed, they will have a bone marrow aspirate/biopsy for biomarker and PD testing and to check the status of the disease.
Length of Treatment:
Participant may continue taking the study drugs for up to 3 cycles of Consolidation after Induction. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation in the study will be over after the follow-up visits.
Follow-Up Visits:
Every 4-8 weeks after participant's last dose of study drugs, blood (about 2-3 teaspoons) will be drawn for routine tests.
Every 6-12 months after the last dose of study drugs, the study staff will check on how participant is doing. This will either be done by phone or during a regularly scheduled clinic visit. If participant is contacted by phone, the phone call should last about 10 minutes.
This follow-up will last until participant withdraws from the study or the study ends.
Long-Term Follow-Up:
After patient's participation in this study is over, they will be given the option to enroll in a long-term follow-up study (DR09-0223). Participant's doctor will explain this to them in more detail, and they will be required to sign a separate consent form.
This is an investigational study. Fludarabine and cytarabine are FDA approved and commercially available for the treatment of leukemia. Erwinase is FDA approved and commercially available for use in acute lymphoblastic leukemia. Its use in this study is investigational. The combination of these drugs is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
- Conditions
- Hematologic Malignancy
- Being tested
- Fludarabine, Cytarabine, Erwinase
- Keywords
- Hematologic malignancy, Relapsed and refractory hematologic malignancies, Acute myeloid leukemia, AML, Acute lymphoblastic leukemia, ALL, Burkitt's leukemia/lymphoma, Prolymphocytic leukemia, Biphenotypic acute leukemia, Blast-phase of chronic myeloid leukemia, CML, B-cell lymphoma, Richter's transformation of chronic lymphocytic leukemia, CLL, Fludarabine, Fludarabine phosphate, Fludara, Cytarabine, Ara-C, Cytosar
- Medical subject headings
- Hematologic Neoplasms, Recurrence, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Burkitt Lymphoma, Lymphoma, Leukemia, Prolymphocytic, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Also called Fludarabine Phosphate, Fludara
Induction Phase:
30 mg/m2 by vein over 15-30 minutes on Days 1 - 5 of a 28 day cycle.
Consolidation Phase:
30 mg/m2 by vein over 15-30 minutes on Days 1 - 4 of a 28 day cycle.
CytarabineDrug
Also called Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine Hydrochloride
Induction Phase:
2 grams/m2 by vein over approximately 2 hours on Days 1 - 5 of a 28 day cycle.
Consolidation Phase:
2 grams/m2 by vein over approximately 2 hours on Days 1 - 4 of a 28 day cycle.
ErwinaseDrug
Also called L-asparaginase, Erwinia L-Asparaginase, Erwinia Chrysanthemi L-asparaginase
Induction Phase:
25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes on Days 1 - 7 of a 28 day cycle.
Consolidation Phase:
25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes every other day on Days 1, 3, 5, 7, 9, 11, 13, 15 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Fludarabine + Cytarabine + Erwinase | Experimental | Induction Phase: Participants receive 1-2 cycles during the Induction phase.
Participants receive 1-2 cycles during the Induction phase.
Participants receive Fludarabine by vein on Days 1-5 and Cytarabine by vein.
Participants receive Erwinase by vein or as an injection into the muscle on Days 1-7.
Consolidation Phase: Participants receive up to 3 cycles during the Consolidation phase.
Participants receive Fludarabine by vein on Days 1-4 and Cytarabine by vein.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant receives Erwinase by vein or as an injection into the muscle. Receives: Drug: Fludarabine; Drug: Cytarabine; Drug: Erwinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
Response assessed according to the Revised Recommendations of the International Working Group Response Criteria in Acute Myeloid Leukemia.
Measured: 56 days
Secondary outcomes (1)
Disease-Free Survival (DFS) of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
DFS calculated from date of remission until the date of first objective documentation of disease-relapse or death.
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 posted24 Mar 2016 (estimated)
- Study startMay 2018 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2022 (estimated)
Why it stopped: Problem with drug supply
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies 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
- Collaborators
- Jazz Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Tapan Kadia, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718755
- Sponsor's protocol ID
- 2015-0807
- Other IDs
- NCI-2016-00691
- Status last verified
- Jun 2018
- First submitted
- 16 Mar 2016
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Fludarabine, Cytarabine (ARA-C) and Erwinase IV in Patients With Relapsed or Refractory Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT02718755
- Acronym / sponsor ID
- 2015-0807
- Conditions
- Hematologic Malignancy
- Keywords
- Hematologic malignancy, Relapsed and refractory hematologic malignancies, Acute myeloid leukemia, AML, Acute lymphoblastic leukemia, ALL, Burkitt's leukemia/lymphoma, Prolymphocytic leukemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problem with drug supply
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Jazz Pharmaceuticals
- Study start
- May 2018 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 24 Mar 2016 (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 fludarabine, cytarabine (ARA-C), and erwinase (also known as asparaginase [erwinia]) in combination can help to control relapsed or refractory hematologic malignancies. The safety of these drugs will also be studied.
Detailed description
Study Drug Administration:
Each cycle is 28 days.
If participant is found to be eligible to take part in this study, they will receive treatment in 2 phases: Induction and Consolidation.
All participants will receive the same dose level of fludarabine, cytarabine, and erwinase. If the doctor thinks it is needed, the study drug doses may be reduced.
Induction Phase:
Participant will receive 1-2 cycles during the Induction phase.
On Days 1-5, participant will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours.
On Days 1-7, participant will receive erwinase by vein over about 2 hours or as an injection into the muscle.
If the disease does not respond during Cycle 1, participant may be allowed to receive an additional Induction cycle. If the disease does respond to Induction, participant can move to the Consolidation phase.
Consolidation Phase:
Participant will receive up to 3 cycles during the Consolidation phase.
On Days 1-4, participant will receive fludarabine by vein over about 30 minutes and cytarabine by vein over about 2 hours. If the doctor thinks it is needed, this may be reduced to Days 1-3.
On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant will receive erwinase by vein over about 2 hours or as an injection into the muscle.
Study Visits:
On Day 1 (± 3 days) of every cycle, participant will have a physical exam.
Induction Cycle(s):
Every week, blood (about 2-3 teaspoons) will be drawn for routine tests.
On Days 1, 8, 9, and 12 of Cycle 1:
- Blood (about 1-2 teaspoons) will be drawn for routine, biomarker, and pharmacodynamic (PD) testing. Biomarkers are found in the blood/tissue and may be related to how the leukemia reacts to the study drug. PD testing measures how the level of study drug in participant's body may affect the disease.
- On Days 9 and 12 only, blood (about 1-2 teaspoons) will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points.
On Day 7 of Cycle 1, blood (about 1-2 teaspoons each time) will be drawn for PK testing before the dose and then 8 more times over the next 24 hours after the dose. Some of these blood samples will also be used for antibody testing. Antibodies are created by the immune system and may attack foreign cells or substances, such as the study drug.
On Day 21 of Cycle 1, participant will have a bone marrow aspiration/biopsy for biomarker and PD testing and to check the status of the disease. If the doctor thinks it is needed, participant may have additional bone marrow aspirations/biopsies while on study.
If participant has a second Induction Cycle and the doctor thinks it is needed, they will have a bone marrow aspirate/biopsy at the end of the second Induction Cycle for biomarker and PD testing and to check the status of the disease.
Consolidation Cycles:
Every 1-2 weeks, blood (about 2-3 teaspoons) will be drawn for routine tests.
On Day 1 of Cycle 1, blood (about 1-2 teaspoons) will be drawn for PK testing before the dose and then 8 more times over the next 24 hours after the dose. Some of this blood sample will also be used for antibody testing.
If participant did not have 2 induction cycles, at the end of Cycle 1 of Consolidation, if the doctor thinks it is needed, they will have a bone marrow aspirate/biopsy for biomarker and PD testing and to check the status of the disease.
Length of Treatment:
Participant may continue taking the study drugs for up to 3 cycles of Consolidation after Induction. Participant will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Patient's participation in the study will be over after the follow-up visits.
Follow-Up Visits:
Every 4-8 weeks after participant's last dose of study drugs, blood (about 2-3 teaspoons) will be drawn for routine tests.
Every 6-12 months after the last dose of study drugs, the study staff will check on how participant is doing. This will either be done by phone or during a regularly scheduled clinic visit. If participant is contacted by phone, the phone call should last about 10 minutes.
This follow-up will last until participant withdraws from the study or the study ends.
Long-Term Follow-Up:
After patient's participation in this study is over, they will be given the option to enroll in a long-term follow-up study (DR09-0223). Participant's doctor will explain this to them in more detail, and they will be required to sign a separate consent form.
This is an investigational study. Fludarabine and cytarabine are FDA approved and commercially available for the treatment of leukemia. Erwinase is FDA approved and commercially available for use in acute lymphoblastic leukemia. Its use in this study is investigational. The combination of these drugs is investigational. The study doctor can explain how the study drugs are designed to work.
Up to 20 participants will be enrolled in this study. All will take part 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 |
|---|---|---|
| Fludarabine + Cytarabine + Erwinase | Experimental | Drug: Fludarabine, Drug: Cytarabine, Drug: ErwinaseInduction Phase: Participants receive 1-2 cycles during the Induction phase. Participants receive 1-2 cycles during the Induction phase. Participants receive Fludarabine by vein on Days 1-5 and Cytarabine by vein. Participants receive Erwinase by vein or as an injection into the muscle on Days 1-7. Consolidation Phase: Participants receive up to 3 cycles during the Consolidation phase. Participants receive Fludarabine by vein on Days 1-4 and Cytarabine by vein. On Day 1 and then every other day for 15 days (3, 5, 7 and so on), participant receives Erwinase by vein or as an injection into the muscle. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients with a diagnosis of relapsed or refractory hematologic malignancy including, but not limited to Acute myeloid leukemia (AML), Acute lymphoblastic leukemia (ALL), Burkitt's leukemia/lymphoma, Prolymphocytic leukemia, Biphenotypic acute leukemia, Blast-phase of chronic myeloid leukemia (CML), B-cell lymphoma, or Richter's transformation of chronic lymphocytic leukemia (CLL)
- Age </= 60 years.
- Adequate organ function as defined below: liver function (bilirubin < 2mg/dL, AST and/or ALT <2.5 x upper limits of normal (ULN)), kidney function (creatinine < 1.5 x ULN ), known cardiac ejection fraction of > or = 45% within the past 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of </= 2.
- 5) A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
Key exclusion criteria (5 listed)
- Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
- Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patient with documented hypersensitivity to any of the components of the chemotherapy program.
- Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
- Patients with history of clinically significant venous thromboembolism.
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 |
|---|---|---|
| FludarabineAlso: Fludarabine Phosphate, FludaraInduction Phase: 30 mg/m2 by vein over 15-30 minutes on Days 1 - 5 of a 28 day cycle. Consolidation Phase: 30 mg/m2 by vein over 15-30 minutes on Days 1 - 4 of a 28 day cycle. | Drug | Fludarabine + Cytarabine + Erwinase |
| CytarabineAlso: Ara-C, Cytosar, DepoCyt, Cytosine Arabinosine HydrochlorideInduction Phase: 2 grams/m2 by vein over approximately 2 hours on Days 1 - 5 of a 28 day cycle. Consolidation Phase: 2 grams/m2 by vein over approximately 2 hours on Days 1 - 4 of a 28 day cycle. | Drug | Fludarabine + Cytarabine + Erwinase |
| ErwinaseAlso: L-asparaginase, Erwinia L-Asparaginase, Erwinia Chrysanthemi L-asparaginaseInduction Phase: 25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes on Days 1 - 7 of a 28 day cycle. Consolidation Phase: 25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes every other day on Days 1, 3, 5, 7, 9, 11, 13, 15 of a 28 day cycle. | Drug | Fludarabine + Cytarabine + Erwinase |
Primary outcome
Overall Response of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
Time frame: 56 days
Response assessed according to the Revised Recommendations of the International Working Group Response Criteria in Acute Myeloid Leukemia.
1 secondary outcome
Disease-Free Survival (DFS) of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies
Time frame: 21 days
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 26 Jun 2018.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Hematologic Malignancy
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Tapan Kadia, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Cytarabine and Erwinase in people with Hematologic Malignancy, 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 26 Jun 2018. 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 of Fludarabine, Cytarabine, and Erwinase in Refractory/Relapsed Hematologic Malignancies (time frame: 56 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 26 Jun 2018.