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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)
Must not have
Active hepatic graft-versus-host disease
Active >= grade 3 peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Summary
This trial tests a combination of chemotherapy drugs to treat patients with certain types of leukemia and lymphoma that have returned or don't respond to usual treatments. The drugs work together to kill cancer cells and stop them from growing. The study aims to see how safe and effective this treatment is.
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.
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.
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active liver complications from a transplant.
Select...
I have severe nerve damage in my hands or feet.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of adverse events
Overall response rate (ORR) (Phase II)
Secondary study objectives
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
~2650
Pegfilgrastim
2013
Completed Phase 3
~4440
Clofarabine
2007
Completed Phase 3
~1130
Bortezomib
2005
Completed Phase 3
~1410
Vincristine Sulfate Liposome
2010
Completed Phase 3
~2580
Cyclophosphamide
2010
Completed Phase 4
~2320
Ofatumumab
2013
Completed Phase 3
~1480
Rituximab
1999
Completed Phase 4
~2200
Etoposide
2010
Completed Phase 3
~2960
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Combination chemotherapy is a common treatment for T-Lymphoblastic Lymphoma/Leukemia, utilizing multiple drugs that work through various mechanisms to combat the disease. These drugs include agents like clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib.
They kill tumor cells by inducing apoptosis, inhibit cell division by interfering with DNA replication and mitosis, and prevent the spread of cancer cells by disrupting cellular processes essential for metastasis. This multifaceted approach is vital for T-Lymphoblastic Lymphoma/Leukemia patients due to the aggressive nature of the disease, aiming to improve survival rates and reduce the likelihood of relapse.
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,048 Previous Clinical Trials
1,799,899 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,872 Previous Clinical Trials
41,010,735 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.
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