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Alkylating agents

Chemotherapy + Immunotherapy for Acute Lymphoblastic Leukemia

Phase 3
Waitlist Available
Led By Mark R Litzow
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi for randomization or assignment to blinatumomab or no blinatumomab
Direct or total bilirubin < 1.5 x ULN for randomization or assignment to blinatumomab or no blinatumomab
Must not have
Mature B ALL (Burkitt's-like leukemia) is excluded from enrollment in this trial; pre-study bone marrow biopsy and aspirate must be completed =< 1 week prior to registration
Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new chemotherapy treatment for leukemia that includes an immunotherapy drug.

Who is the study for?
Adults aged 30-70 with a new diagnosis of BCR-ABL-negative B lineage acute lymphoblastic leukemia (ALL) are eligible. They must have normal kidney and liver function, not be pregnant or breastfeeding, use contraception if necessary, and have no recent severe heart issues. HIV-positive patients can join under certain conditions.
What is being tested?
The trial is testing whether adding the immunotherapy drug Blinatumomab to standard combination chemotherapy improves outcomes in treating newly diagnosed ALL compared to chemotherapy alone.
What are the potential side effects?
Chemotherapy may cause nausea, hair loss, fatigue, increased infection risk, and organ damage. Blinatumomab might lead to immune system reactions like fever or difficulty breathing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood tests show I am in remission from cancer.
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My bilirubin levels are less than 1.5 times the upper limit.
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My kidney function, measured by creatinine, is within the normal range.
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My bone marrow sample will be tested for minimal residual disease.
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I can care for myself but may not be able to do heavy physical work.
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I am between 30 and 70 years old.
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My leukemia diagnosis was confirmed through specific blood tests.
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My tests show I do not have the Philadelphia chromosome in my cancer cells.
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I can care for myself after initial cancer treatment.
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My cancer responded completely to the initial treatment.
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I can care for myself but may not be able to do heavy physical work.
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I can care for myself and am up and about more than 50% of my waking hours.
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My blood tests show I am currently in remission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have Burkitt's-like leukemia and had a bone marrow test within the last week.
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I do not have any significant brain or nervous system conditions.
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I do not have any current infections that aren't under control.
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I am not currently being treated for another cancer.
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I have never had a blood disorder before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 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
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Secondary study objectives
OS Among MRD Negative Patients Who Proceed to Allogeneic Transplant on Study
OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
+1 more
Other study objectives
Incidence of Anti-blinatumomab Antibody Formation
To Determine Differences in MRD Kinetics Among Patients With the BCR/ABL1-like B-lineage ALL, and to Compare the OS (and RFS) of Patients With BCR-ABL-like Phenotype With Those Without BCR-ABLlike Phenotype

Side effects data

From 2022 Phase 3 trial • 111 Patients • NCT02393859
80%
Pyrexia
43%
Nausea
37%
Headache
31%
Vomiting
24%
Anaemia
22%
Diarrhoea
20%
Stomatitis
17%
Mucosal inflammation
13%
Abdominal pain
13%
Platelet count decreased
13%
Rash
13%
Hypertension
11%
Pruritus
11%
Hypokalaemia
11%
Erythema
11%
Hypogammaglobulinaemia
11%
Hypotension
9%
Neutropenia
9%
Epistaxis
9%
Tremor
9%
Constipation
9%
Neutrophil count decreased
7%
White blood cell count decreased
7%
Immunodeficiency
7%
Alanine aminotransferase increased
7%
Agitation
7%
Hypervolaemia
7%
Anal inflammation
7%
Cough
7%
Thrombocytopenia
7%
Abdominal pain upper
7%
Petechiae
7%
Fluid overload
6%
Decreased appetite
6%
Back pain
6%
Fatigue
6%
Paronychia
6%
Rash maculo-papular
6%
Nasopharyngitis
6%
Febrile neutropenia
6%
Urticaria
4%
Fluid balance positive
4%
Seizure
4%
Oropharyngeal pain
4%
Aplasia
4%
Pain in extremity
4%
Neurological symptom
4%
Aspartate aminotransferase increased
2%
Oral pain
2%
Complication associated with device
2%
Nervous system disorder
2%
Engraftment syndrome
2%
Klebsiella infection
2%
Perineal cellulitis
2%
Accidental overdose
2%
Herpes virus infection
2%
Blood immunoglobulin G decreased
2%
Haematoma
2%
Neurological examination abnormal
2%
Catheter placement
2%
Antithrombin III decreased
2%
Laryngotracheitis obstructive
2%
Pain
2%
Hypertransaminasaemia
2%
Rhinitis
2%
Body temperature increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab
HC3 Chemotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (blinatumomab, chemotherapy)Experimental Treatment21 Interventions
See Detailed Description
Group II: Arm II (chemotherapy)Active Control20 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2030
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Lumbar Puncture
2016
Completed Phase 3
~510
Vincristine Sulfate
2005
Completed Phase 3
~10270
Daunorubicin Hydrochloride
2011
Completed Phase 3
~5330
Leucovorin Calcium
2011
Completed Phase 3
~12500
Methotrexate
2019
Completed Phase 4
~4400
Cytarabine
2016
Completed Phase 3
~3330
Pegaspargase
2005
Completed Phase 3
~9260
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1240
Cyclophosphamide
2010
Completed Phase 4
~2310
Daunorubicin
2013
Completed Phase 4
~5040
Dexamethasone
2007
Completed Phase 4
~2650
Etoposide
2010
Completed Phase 3
~2960
Mercaptopurine
2012
Completed Phase 4
~12550
Prednisone
2014
Completed Phase 4
~2500
Rituximab
1999
Completed Phase 4
~2990
Vincristine
2003
Completed Phase 4
~2970
Blinatumomab
2014
Completed Phase 3
~1230

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,022,700 Total Patients Enrolled
Canadian Cancer Trials GroupNETWORK
132 Previous Clinical Trials
69,379 Total Patients Enrolled
Mark R LitzowPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT02003222 — Phase 3
Acute Lymphoblastic Leukemia Research Study Groups: Arm II (chemotherapy), Arm I (blinatumomab, chemotherapy)
Acute Lymphoblastic Leukemia Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02003222 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02003222 — Phase 3
~42 spots leftby Dec 2025
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