Study Summary
This trial is testing a chemotherapy combination with the drug nelarabine to treat T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
Eligible Conditions
- Acute Lymphoblastic Leukemia
- T-Cell Lymphoblastic Lymphoma
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: Up to 9 years
3 years
Complete remission rate
Overall survival
Progression-free survival
Up to 9 years
Duration of remission
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Saline
47%Anemia
41%Nausea
31%Lymphocyte count decreased
28%Fatigue
28%Neutrophil count decreased
28%White blood cell decreased
13%Headache
13%Hypoatremia
13%Platelet count decreased
13%Constipation
13%Paresthesia
9%Cough
9%Alanine aminotransferase increased
9%Hypocalcemia
9%Hypokalemia
9%Myalgia
9%Vomiting
9%Hypoalbuminemia
6%Febrile neutropenia
6%Hypernatremia
6%Mucositis oral
6%Pain
6%Chills
6%Dyspnea
6%Edema Limbs
6%Flank Pain
6%Insomnia
3%Fibrinogen decreased
3%Gastritis
3%Depression
3%Hypomagnesemia
3%Hypotension
3%Non-cardiac chest pain
3%Pain in extremity
3%Palpitations
3%Pruritus
3%Sore Throat
3%Vaginal Infection
3%Wheezing
3%Blurred Vision
3%MRSA positive infection in toe
3%Alkaline phosphatase increased
3%Blood bilirubin increased
3%Allergic rhinitis
3%Anorexia
3%Lung Infection
3%Arthralgia
3%Dermatitis
3%Creatinine increased
3%Diarrhea
3%Esophageal Spasms
3%Hemorrhoids
3%Hyperglycemia
3%Lip Infection
3%Muscle weakness upper limb
3%Rash maculo-papular
3%Urinary Frequency
Trial Design
1 Treatment Group
Treatment (nelarabine and combination chemotherapy)
1 of 1
Experimental Treatment
160 Total Participants · 1 Treatment Group
Primary Treatment: Cyclophosphamide · No Placebo Group · Phase 2
Treatment (nelarabine and combination chemotherapy)Experimental Group · 11 Interventions: Nelarabine, Prednisone, Cyclophosphamide, Cytarabine, Dexamethasone, Methotrexate, Doxorubicin Hydrochloride, Pegaspargase, Mercaptopurine, Venetoclax, Vincristine Sulfate · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nelarabine
FDA approved
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Cytarabine
FDA approved
Dexamethasone
FDA approved
Methotrexate
FDA approved
Doxorubicin
FDA approved
Pegaspargase
FDA approved
Mercaptopurine
FDA approved
Venetoclax
FDA approved
Vincristine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 9 years
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,825 Previous Clinical Trials
1,792,411 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,153 Previous Clinical Trials
41,162,764 Total Patients Enrolled
Farhad Ravandi-KashaniPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
395 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 5 Total Inclusion Criteria
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