Clinical Efficacy of MOAP Regimen for Relapsed/Refractory cHL as a Rescue Therapy After DP Regimen

Hodgkin Lymphoma Clinical Trial

Official title:

Clinical Efficacy of MOAP Regimen for Relapsed/Refractory Classical Hodgkin's Lymphoma as a Rescue Therapy After Ineffective Treatment of Additional Low-dose Decitabine to Anti-PD-1 Antibody Camrelizumab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04026269
• Other study ID #: CHN-PLAGH-BT-043
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 30, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Chinese PLA General Hospital
• Contact: Weidong Han
• Phone: 86(10)66937463
• Email: hanwdrsw[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The DP regimen, low-dose decitabine combined with SHR-1210, is the new treatment for relapsed or refractory classical Hodgkin's Lymphoma. Though the CR rate of this regimen is impressively high, which is verified more than 70% in our I/II phase study, there are also lots of patients cannot benefit from this treatment. On top of that, as the increasing utilization of mono-therapy or combination treatment with the immune checkpoint blockade (ICB), the adverse reactions associated with immunotherapy make it unavailable in parts of patients. The application of MOAP regimen to patients, who have a progressive disease after DP regimen, can bring high CR rate. MOAP can be the a rescue treatment for cHL resisted to DP treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subjects must have histological confirmation of relapsed or refractory Hodgkin lymphoma (HL).

2. 13 to 70 years of age.

3. ECOG performance of less than 2.

4. Life expectancy of at least 3 months.

5. Subjects with lymphoma must have at least one measureable lesion >1 cm as defined by lymphoma response criteria.

6. Subjects must have received at least two prior chemotherapy regimen and four cycle of DP regimen, and must be off therapy for at least 4 weeks prior to Day 1. Subjects with autologous hematopoietic stem-cell transplantation are eligible which must be more than 3 months.

7. Subjects must have adequate marrow, live, renal and heart functions.

Exclusion Criteria:

1. Subjects with any autoimmune disease or history of syndrome that requires corticosteroids or immunosuppressive medications.

2. Serious uncontrolled medical disorders or active infections, pulmonary infection especially.

3. Active alimentary tract hemorrhage or history of alimentary tract hemorrhage in 1 month .

4. Prior organ allograft.

5. Women who are pregnant or breastfeeding.

6. Women with a positive pregnancy test on enrollment or prior to investigational product administration.

7. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• MOAP
the new chemotherapy regimen for r/r cHL

Locations

Country	Name	City	State
China	Biotherapeutic Department of Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Han weidong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRR assess by investigators per the 2014 Lugano classification	Time measured from the day of first documented PR or CR to the date of first rate of subjects achieved complete response in all evaluable subjects	3 years
Primary	Number of Subjects with treatment-related adverse events (AEs)	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.	2 years
Primary	duration of CR	Time measured from the day of first documented CR to the date of first documented progression, or death from any cause.	5 years