EDOCH Alternating With DHAP for New Diagnosed Younger MCL

NCT02858804 | Completed Phase 4

• 1 other identifier: IIT2015007
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.determine the efficiency of EDOCH (etoposide,dexamethasone,doxorubicin, cyclophosphamide and vincristine) alternating with DHAP (cisplatin, cytarabine and dexamethasone) regimen combined with rituximab or not in young mantle cell lymphoma patients (age≤65 years);
2. 2.determine the efficiency of rituximab and thalidomide plus prednisone as maintenance regimens.

Conditions

Mantle Cell Lymphoma

Keywords

mantle cell lymphoma; EDOCH; DHAP; maintenance therapy

Outcome Measures

Primary Outcomes (1)

• progression free survival

  the time interval between diagnosis and disease progression or death or last follow-up

  up to 36 months

Secondary Outcomes (2)

• complete remission

  up to 6 months

• overall survival

  up to 36 months

Study Arms (10)

Etoposide

EXPERIMENTAL

50 mg/m2, IV, d1-4

Drug: Etoposide

Doxorubicin

EXPERIMENTAL

10 mg/m2, IV, d1-4

Drug: Doxorubicin

Dexamethasone

EXPERIMENTAL

30 mg/d, d1-5

Drug: Dexamethasone

Vincristine

EXPERIMENTAL

0.4 mg/m2, IV, d1-4

Drug: Vincristine

Cyclophosphamide

EXPERIMENTAL

750 mg/m2 ,d5

Drug: Cyclophosphamide

Cytarabine

EXPERIMENTAL

2g/m2, q12h, d1

Drug: Cytarabine

Cisplatin

EXPERIMENTAL

100mg/ m2,IV, d1

Drug: Cisplatin

Rituximab

EXPERIMENTAL

375 mg/m2 IV, d1

Drug: Rituximab

Thalidomide

EXPERIMENTAL

50-150mg/d, po, d1-28

Drug: Thalidomide

Prednisone

EXPERIMENTAL

0.5mg/Kg, po, qod

Drug: Prednisone

Interventions

Etoposide DRUG

50 mg/m2, IV d1-4

Also known as: VP-16

Etoposide

Doxorubicin DRUG

10 mg/m2, IV, d1-4

Also known as: adriamycin

Doxorubicin

Dexamethasone DRUG

30 mg/d, d1-5

Also known as: Dex

Dexamethasone

Vincristine DRUG

0.4 mg/m2, IV, d1-4

Also known as: VCR

Vincristine

Cyclophosphamide DRUG

750 mg/m2 ,d5

Also known as: CTX

Cyclophosphamide

Cytarabine DRUG

2g/m2, q12h, d1

Also known as: Ara-c

Cytarabine

Cisplatin DRUG

100mg/ m2,IV, d1

Also known as: DDP

Cisplatin

Rituximab DRUG

375 mg/m2 IV, d1

Also known as: R

Rituximab

Thalidomide DRUG

50-150mg/d, po, d1-28

Also known as: Thal

Thalidomide

Prednisone DRUG

0.5mg/Kg, po, qod

Also known as: Pred

Prednisone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age≤65 years
• diagnosis with mantle cell lymphoma
• Ann Arbor stage II,III or IV
• ECOG≤1 or if ECOG≥2 but recover after pretreatment.

You may not qualify if:

• with centre neural system involvement
• serious complications such as uncontrolled diabetes, gastric ulcer or other serious angiocardiopathy determined by the physician
• HIV positive or active HBV infection or other uncontrolled systematic infection
• clinical central nervous dysfunction
• serious surgery within 30 days
• pregnancy or baby nursing period or un-contracepted child bearing period woman.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Shuhua Yi

Tianjin, 300020, China

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Etoposide; Doxorubicin; Dexamethasone; Vincristine; Cyclophosphamide; Cytarabine; Cisplatin; Rituximab; Thalidomide; Prednisone; prednylidene

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Daunorubicin; Anthracyclines; Naphthacenes; Aminoglycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Pregnadienediols

Study Officials

• Shuhua Yi, Doc

  Blood disease hospital, Chinese Academic Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2016
• First Posted: August 8, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: February 11, 2026

Record last verified: 2024-05

Locations

CN (1)