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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
No Placebo-Only Group

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.
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.
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 below
Select...
I am capable of limited self-care and spend less than half of my day in bed or a chair.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 9 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete remission rate
Duration of remission
Overall survival
+1 more

Side effects data

From 2023 Phase 2 trial • 27 Patients • NCT04002401
88%
Pyrexia
65%
Neutrophil count decreased
62%
Nausea
58%
Hypotension
50%
Anaemia
46%
Headache
38%
Fatigue
38%
Decreased appetite
35%
Confusional state
31%
Tachycardia
31%
Diarrhoea
31%
Hypokalaemia
27%
Constipation
27%
Hypophosphataemia
27%
Back pain
23%
Dizziness
23%
Tremor
23%
B-cell lymphoma
23%
Platelet count decreased
23%
White blood cell count decreased
19%
Cough
19%
Agitation
19%
Hyponatraemia
19%
Neutropenia
19%
Tachypnoea
19%
Hypogammaglobulinaemia
19%
Oedema peripheral
15%
Hypomagnesaemia
15%
Thrombocytopenia
15%
Dysphagia
15%
Alanine aminotransferase increased
15%
Sinus tachycardia
15%
Chills
15%
Dyspnoea
12%
Aspartate aminotransferase increased
12%
Pain
12%
Arthralgia
12%
Myalgia
12%
Hypertension
12%
Hyperglycaemia
12%
Hypoxia
12%
Vomiting
12%
Abdominal pain
12%
Peripheral sensory neuropathy
12%
Covid-19
12%
Malaise
8%
Dysuria
8%
Muscular weakness
8%
Blood creatinine increased
8%
Hyperhidrosis
8%
Insomnia
8%
Acute myeloid leukaemia
8%
Encephalopathy
8%
Sepsis
8%
Pancytopenia
8%
Eye pain
8%
Urinary tract infection
8%
Lymphocyte count decreased
8%
Asthenia
8%
Somnolence
8%
Oral candidiasis
8%
Pneumonia
8%
Gait disturbance
8%
Aphasia
4%
Pleural effusion
4%
Depression
4%
Embolism
4%
Syncope
4%
Respiratory failure
4%
Febrile neutropenia
4%
Covid-19 pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Axicabtagene Ciloleucel and Rituximab Combination

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
~2500
Cyclophosphamide
2010
Completed Phase 4
~2310
Cytarabine
2016
Completed Phase 3
~3330
Dexamethasone
2007
Completed Phase 4
~2650
Methotrexate
2019
Completed Phase 4
~4400
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Pegaspargase
2005
Completed Phase 3
~9260
Mercaptopurine
2012
Completed Phase 4
~12550
Venetoclax
2019
Completed Phase 3
~2240
Vincristine Sulfate
2005
Completed Phase 3
~10270

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,085 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,841 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
8 Previous Clinical Trials
606 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00501826 — Phase 2
Acute Lymphoblastic Leukemia Research Study Groups: Treatment (nelarabine and combination chemotherapy)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00501826 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00501826 — Phase 2
~16 spots leftby Oct 2026
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