Acute Lymphoblastic LeukemiaPhase 2NCT03023046

Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin in Treating Patients With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

A Phase 2 study testing Cyclophosphamide, Dasatinib and Doxorubicin in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
What is being tested?: Cyclophosphamide, Dasatinib and Doxorubicin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 23 Feb 2017to 1 May 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have a confirmed diagnosis of either:
Acute lymphoblastic leukemia
Lymphoblastic lymphoma with detectable abnormal blasts in the bone marrow
In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (i.e., >= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen, or Ph+ disease
Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)
Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 x institutional ULN; (Note: patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 5.0 x ULN and ALT/AST are =< 8.0 x ULN)

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Creatinine =< 2.0 mg/dL; however, patients with a creatinine > 2.0 mg/dL but with a calculated creatinine clearance of > 30 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible
As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles)
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2; (performance status of 3 will be allowed if poor performance status is thought to be directly secondary to ALL)
Must agree to the use of effective contraception while on study treatment, unless they are highly unlikely to conceive (defined as [1] surgically sterilized, or [2] postmenopausal [i.e., a woman who is > 50 years old or who has not had menses for >= 1 year], or [3] not heterosexually active for the duration of the study)
Ability to give informed consent and comply with the protocol
Anticipated survival of at least 3 months, independent of ALL

Who cannot join

Patients with Burkitt lymphoma/leukemia
Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Patients with isolated extramedullary disease or with known parenchymal central nervous system (CNS) disease
Known hypersensitivity or intolerance to any of the agents under investigation
Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol
May not be pregnant or nursing

Trial locations and contacts

1 site in 1 country.

United States1 site

Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109

Other trials in United States

About this study

Official title: A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma

This phase II trial studies how well etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin (DA-EPOCH) works in treating patients with acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Being tested: Cyclophosphamide, Dasatinib, Doxorubicin, Etoposide, Imatinib Mesylate
Medical subject headings: Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
DasatinibDrug
Also called BMS-354825, Sprycel, 5-Thiazolecarboxamide, Dasatinib Hydrate
Given PO
DoxorubicinDrug
Also called Adriablastin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Given IV
EtoposideDrug
Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar
Given IV
Imatinib MesylateDrug
Also called CGP 57148, CGP57148B, Gleevec, Glivec
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
PrednisoneDrug
Also called .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl
Given PO
RituximabBiological
Also called ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody
Given IV
Vincristine SulfateDrug
Also called Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin
Given IV

Study groups in NCT03023046
Study group	Role	What they receive
Treatment (chemotherapy)	Experimental	Patients receive etoposide IV over 96 hours, doxorubicin IV over 96 hours, and vincristine sulfate IV over 96 hours on days 1-4. Patients also receive cyclophosphamide IV over 1 hour on day 5 and prednisone PO BID on days 1-5. Patients who are Ph+ also receive imatinib mesylate or dasatinib PO QD on days 1-14. Patients who are CD20+ also receive rituximab IV on day 1 or day 5. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Receives: Drug: Cyclophosphamide; Drug: Dasatinib; Drug: Doxorubicin; Drug: Etoposide; Drug: Imatinib Mesylate; Other: Laboratory Biomarker Analysis; Drug: Prednisone; Biological: Rituximab; Drug: Vincristine Sulfate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Morphological Complete Response Rate
Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL.
Measured: Within 4 cycles of study therapy
Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable.
When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed.
Measured: Within 4 cycles of study therapy

Secondary outcomes (3)

Number of Participants With Adverse Events
Grade 1 or higher non-hematologic adverse events will be assessed by Common Terminology Criteria for Adverse Events version 5.0.
Measured: Within 28 days of the last dose of the study drugs
Overall Survival
Alive at 2 years after enrollment
Measured: Up to 2 years
Event-free Survival
Events were defined as any of the following: (1) unable to achieve either morphologic complete remission (CR) or MRD- by MFC, (2) relapse after CR, (3) MRD recurrence after achieving MRD-, or (4) death from any cause.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 20171 May 2022

First posted18 Jan 2017 (estimated)
Study start23 Feb 2017
Primary completion20 May 2021
Study completion1 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03023046
Sponsor's protocol ID: 9770
Other IDs: NCI-2016-02050, 9770, P30CA015704, RG1016012
Status last verified: Jun 2022
First submitted: 10 Jan 2017
Last updated: 13 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Lymphoblastic Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) as Front-Line Therapy for Adults With Acute Lymphoblastic Leukemia/Lymphoma
ClinicalTrials.gov ID: NCT03023046
Acronym / sponsor ID: 9770
Conditions: Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 23 Feb 2017 (actual)
Primary completion: 20 May 2021 (actual)
Study completion: 1 May 2022 (actual)
First posted: 18 Jan 2017 (estimated)
Results: Posted 13 Jul 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (chemotherapy)	Experimental	Drug: Cyclophosphamide, Drug: Dasatinib, Drug: Doxorubicin, Drug: Etoposide, Drug: Imatinib Mesylate, Other: Laboratory Biomarker Analysis, Drug: Prednisone, Biological: Rituximab, Drug: Vincristine SulfatePatients receive etoposide IV over 96 hours, doxorubicin IV over 96 hours, and vincristine sulfate IV over 96 hours on days 1-4. Patients also receive cyclophosphamide IV over 1 hour on day 5 and prednisone PO BID on days 1-5. Patients who are Ph+ also receive imatinib mesylate or dasatinib PO QD on days 1-14. Patients who are CD20+ also receive rituximab IV on day 1 or day 5. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Patients must have a confirmed diagnosis of either:
In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (i.e., >= 40 years), practical/logistical barriers to or toxicity concerns from administration of a pediatric-inspired regimen, or Ph+ disease
Total bilirubin =< 2.0 x institutional upper limit of normal ([ULN]; unless attributable to Gilbert's disease or other causes of inherited indirect hyperbilirubinemia, at which point total bilirubin must be =< 4.0 x ULN)
Aspartate aminotransferases (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5.0 x institutional ULN; (Note: patients with liver test abnormalities attributable to hepatic involvement by ALL will be permitted if the total bilirubin is =< 5.0 x ULN and ALT/AST are =< 8.0 x ULN)
Creatinine =< 2.0 mg/dL; however, patients with a creatinine > 2.0 mg/dL but with a calculated creatinine clearance of > 30 ml/min, as measured by the Modification of Diet in Renal Disease (MDRD) equation, will be eligible

Key exclusion criteria (6 listed)

Patients with Burkitt lymphoma/leukemia
Patients must not have received any prior systemic therapy for ALL, except for the acute management of hyperleukocytosis or acute symptoms (e.g., corticosteroids, cytarabine, etc.)
Patients with isolated extramedullary disease or with known parenchymal central nervous system (CNS) disease
Known hypersensitivity or intolerance to any of the agents under investigation
Other medical or psychiatric conditions that in the opinion of the investigator would preclude safe participation in the protocol

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV	Drug	Treatment (chemotherapy)
DasatinibAlso: BMS-354825, Sprycel, 5-Thiazolecarboxamide, Dasatinib HydrateGiven PO	Drug	Treatment (chemotherapy)
DoxorubicinAlso: Adriablastin, Hydroxyl Daunorubicin, HydroxyldaunorubicinGiven IV	Drug	Treatment (chemotherapy)
EtoposideAlso: Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, ToposarGiven IV	Drug	Treatment (chemotherapy)
Imatinib MesylateAlso: CGP 57148, CGP57148B, Gleevec, GlivecGiven PO	Drug	Treatment (chemotherapy)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (chemotherapy)
PrednisoneAlso: .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, CortancylGiven PO	Drug	Treatment (chemotherapy)
RituximabAlso: ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 AntibodyGiven IV	Biological	Treatment (chemotherapy)
Vincristine SulfateAlso: Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, OncovinGiven IV	Drug	Treatment (chemotherapy)

Primary outcome

Number of Participants With Morphological Complete Response Rate
Time frame: Within 4 cycles of study therapy
Morphological complete remission (CR) was determined by bone marrow aspirate morphology and defined as <5% blasts by morphology, absolute neutrophil count >1000/uL, and platelet count >100,000/uL.
Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate
Time frame: Within 4 cycles of study therapy
Response was determined by having no detectable disease by multiparameter flow cytometry (MFC-). For Ph+ subjects, complete molecular response (CMR) by BCR-ABL RT-PCR was assigned when MFC was undetectable. When no measurable residual disease was detected by MFC (MFC-) per EuroFlow criteria, high-throughput sequencing-based MRD testing (HTS; ClonoSEQ) was performed.

3 secondary outcomes

Number of Participants With Adverse Events
Time frame: Within 28 days of the last dose of the study drugs
Overall Survival
Time frame: Up to 2 years
Event-free Survival
Time frame: Up to 2 years

Results and safety

Results posted to the registry on 13 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Chemotherapy)	54	53

Primary outcome: Number of Participants With Morphological Complete Response Rate

Time frame: Within 4 cycles of study therapy. Count of participants. Unit: Participants

Measure	Ph+ Subjects n = 28	Ph- Subjects n = 25
Value	27	20

Primary outcome: Number of Participants With Complete Measurable Residual Disease (MRD) Response Rate

Time frame: Within 4 cycles of study therapy. Count of participants. Unit: Participants

Measure	Ph+ Subjects n = 28	Ph- Subjects n = 25
MFC-: Achieve within 4 cycles	20	16
MFC-: Not achieved within 4 cycles	8	9
CMR: Achieve within 4 cycles	11	–
CMR: Not achieved within 4 cycles	17	–
HTS-: Achieve within 4 cycles	8	6
HTS-: Not achieved within 4 cycles	16	16

Population analysed: HTS- percentages were calculated after excluding patients (Ph+, n = 4; Ph-, n = 3) that were unable to have HTS testing performed for technical reasons.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the time patient signs consent through 30 days following discontinuation of study treatment, or until patient receives alternative anti-cancer therapy, whichever date comes first, up to 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Chemotherapy)	32 of 53 (60.4%)	14 of 53 (26.4%)	18 of 53

Limitations and caveats (from the sponsor): The sample sizes in this study are relatively small, making it difficult to draw definitive conclusions regarding response rate and survival with this regimen.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan D. Cassaday principal investigator

Fred Hutch/University of Washington Cancer Consortium

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclophosphamide, Dasatinib and Doxorubicin in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Morphological Complete Response Rate (time frame: Within 4 cycles of study therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023046.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.