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Proteasome inhibitor
Combination Chemotherapy for Acute Lymphoblastic Leukemia
Phase 2
Recruiting
Led By Maro Ohanian
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age older than 15 years
Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (Lead-in and Phase II)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat leukemia, lymphoma, and other blood cancers that have come back or didn't respond to other treatments.
Who is the study for?
This trial is for people over 15 with certain types of blood cancers like acute lymphoblastic leukemia or Burkitt lymphoma that have returned or are treatment-resistant. Participants need normal liver function, not be pregnant or breastfeeding, and can't have severe nerve damage or active hepatitis B/C.Check my eligibility
What is being tested?
The study tests a combination chemotherapy regimen using drugs like clofarabine, etoposide, cyclophosphamide, and others to see how well they work against aggressive blood cancers when previous treatments failed.See study design
What are the potential side effects?
Chemotherapy may cause side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, bleeding problems from low platelets and potential damage to organs like the heart and kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 15 years.
Select...
My leukemia or lymphoma has returned or didn't respond to treatment and is not Philadelphia chromosome positive.
Select...
My kidneys are functioning well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events
Overall response rate (ORR) (Phase II)
Secondary outcome measures
Event free survival
Overall survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (combination chemotherapy)Experimental Treatment9 Interventions
See detailed description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Pegfilgrastim
2013
Completed Phase 3
~4410
Clofarabine
2007
Completed Phase 3
~1130
Bortezomib
2005
Completed Phase 2
~1140
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580
Cyclophosphamide
1995
Completed Phase 3
~3770
Ofatumumab
2013
Completed Phase 3
~1470
Rituximab
1999
Completed Phase 4
~1880
Etoposide
2010
Completed Phase 3
~2440
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,279 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,664 Previous Clinical Trials
40,926,091 Total Patients Enrolled
Maro OhanianPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
158 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 15 years.I can care for myself but may not be able to do any physical work.I have active liver complications from a transplant.My leukemia or lymphoma has returned or didn't respond to treatment and is not Philadelphia chromosome positive.It's been over 3 weeks since my last chemotherapy, or 2 weeks if my cancer was worsening quickly.My leukemia has returned or didn't respond to treatment and is a specific type.I have severe nerve damage in my hands or feet.My kidneys are functioning well.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (combination chemotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities available for patients to join this research endeavor?
"The clinical trial, which was submitted to the public domain on August 9th 2017 and revised on September 21st 2022, is actively looking for eligible participants."
Answered by AI
What other experiments have been carried out to evaluate the efficacy of Clofarabine?
"Currently, 1844 clinical trials for Clofarabine are being conducted worldwide. Of these active studies, 402 have reached Phase 3 of the trial process. The majority of those trials can be found in Ascoli Piceno, Provincia but there are 61652 other locations that offer this treatment to patients."
Answered by AI
What potential threats are associated with Clofarabine usage?
"Clofarabine's safety is rated a 2, as it has only been tested in the second phase of clinical trials without any evidence for long-term efficacy."
Answered by AI
Can you tell me the aggregate number of participants in this experiment?
"Indeed, according to the clinicaltrials.gov database, this medical trial is actively recruiting patients as of September 21st 2022. The initial posting was on August 9th 2017 and requires 42 participants from a single location."
Answered by AI
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