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Alkylating agents
Combination Chemotherapy + Nelarabine for Leukemia and Lymphoma
Phase 2
Recruiting
Led By Farhad Ravandi-Kashani
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
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 9 years
Awards & highlights
Study Summary
This trial is testing a chemotherapy combination with the drug nelarabine to treat T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
Who is the study for?
This trial is for patients with T-cell acute lymphoblastic leukemia or lymphoma who haven't been treated before, or those who didn't respond to one chemo treatment but are now in remission after up to two courses. They must have acceptable levels of bilirubin and creatinine, liver enzymes no more than four times the normal limit, and be able to perform daily activities (ECOG status ≤3). Pregnant or nursing women can't participate.Check my eligibility
What is being tested?
The study tests how well a combination of chemotherapy drugs works against certain blood cancers. It includes Prednisone, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Methotrexate, Doxorubicin Hydrochloride, Pegaspargase, Mercaptopurine,Venetoclax,and Vincristine Sulfate.See study design
What are the potential side effects?
Possible side effects include nausea,vomiting,hair loss,fatigue,infections due to low blood cell counts,liver problems,kidney issues,mouth sores,and allergic reactions.Some drugs may also cause heart damage or nervous system effects like numbness.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am capable of limited self-care and spend less than half of my day in bed or a chair.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 9 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete remission rate
Duration of remission
Overall survival
+1 moreSide effects data
From 2023 Phase 2 trial • 27 Patients • NCT0400240188%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Decreased appetite
38%
Fatigue
35%
Confusional state
31%
Hypokalaemia
31%
Diarrhoea
31%
Tachycardia
27%
Constipation
27%
Back pain
27%
Hypophosphataemia
23%
Dizziness
23%
Platelet count decreased
23%
Tremor
23%
B-cell lymphoma
23%
White blood cell count decreased
19%
Oedema peripheral
19%
Neutropenia
19%
Cough
19%
Hypogammaglobulinaemia
19%
Hyponatraemia
19%
Tachypnoea
19%
Agitation
15%
Alanine aminotransferase increased
15%
Thrombocytopenia
15%
Chills
15%
Dyspnoea
15%
Hypomagnesaemia
15%
Sinus tachycardia
15%
Dysphagia
12%
Hypertension
12%
Vomiting
12%
Abdominal pain
12%
Aspartate aminotransferase increased
12%
Pain
12%
Malaise
12%
Myalgia
12%
Hypoxia
12%
Arthralgia
12%
Hyperglycaemia
12%
Covid-19
12%
Peripheral sensory neuropathy
8%
Hyperhidrosis
8%
Aphasia
8%
Pancytopenia
8%
Muscular weakness
8%
Pneumonia
8%
Encephalopathy
8%
Eye pain
8%
Gait disturbance
8%
Oral candidiasis
8%
Urinary tract infection
8%
Sepsis
8%
Blood creatinine increased
8%
Acute myeloid leukaemia
8%
Insomnia
8%
Somnolence
8%
Dysuria
8%
Asthenia
8%
Lymphocyte count decreased
4%
Pleural effusion
4%
Covid-19 pneumonia
4%
Respiratory failure
4%
Febrile neutropenia
4%
Embolism
4%
Depression
4%
Syncope
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (nelarabine and combination chemotherapy)Experimental Treatment11 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelarabine
2008
Completed Phase 2
~500
Prednisone
2014
Completed Phase 4
~2370
Cyclophosphamide
1995
Completed Phase 3
~3770
Cytarabine
2016
Completed Phase 3
~3310
Dexamethasone
2007
Completed Phase 4
~2590
Methotrexate
2013
Completed Phase 4
~3800
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Pegaspargase
2005
Completed Phase 3
~9010
Mercaptopurine
2012
Completed Phase 4
~12330
Venetoclax
2019
Completed Phase 3
~1990
Vincristine Sulfate
2005
Completed Phase 3
~10150
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,275 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,694 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
546 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have T cell ALL or lymphoma and haven't been treated, or only had one chemotherapy course.My kidney function, measured by creatinine, is within the acceptable range.I am capable of limited self-care and spend less than half of my day in bed or a chair.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nelarabine and 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.
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