Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin's lymphoma before transplantation

Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin's lymphoma before transplantation - BV-ESHAP for relapsed and refractory Hodgkin's lymphoma

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019361

Enrollment

Registered

2015-10-16

Start date

2015-10-06

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkin&#39

Interventions

3 to 4 courses of BV therapy(1 course for 21 days) &lt

BV therapy&gt

BV 1.8mg/kg day1 Consequently, 1 to 2 courses of ESHAP therapy (1 course for 21 to 28 days) &lt

ESHAP therapy&gt

ETP 40mg/m^2 1h div day1,2,3,4 CDDP 25mg/m^2 24hr cont day1,2,3,4 AraC 2g/m^2 2hrs day5 mPSL 500mg/day 30min div day1,2,3,4,5 Administer G-CSF from day7. Collect peripheral blood stem cells.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: CD30 positive lymphoma cells are confirmed and met all the follows: Announced that patient is Hodgkin's lymphoma. Considered that Hodgkin's lymphoma is refractory or relapsed. Eligible for autologous transplantation. Performance status is 0 to 3. Have any calculable lesion radiographically. AST, ALT is under 2.5 times upper limit of normal controls, and total bilirubin is under 2.0 mg/dl. Creatinine is under 1.5 mg/dl. Showed no severe abnormalities on echocardiograms and ultrasonic cardiography. Showed no interstitial pneumonia. Have written consents from the patient. For those under 20 years old, written consents of both the patient and his replacement is required.

Exclusion criteria

Exclusion criteria: AST, ALT is over 2.5 times upper limit of normal controls, or total bilirubin is over 2.0mg/dl.(exclude for abnormal due to primary disease) Creatinine is over 1.5 mg/dl. Showed severe abnormalities on echocardiograms or ultrasonic cardiography, or congestive heart failure. Have severe interstitial pneumonia, or past history of interstitial pneumonia. Allergic to etoposide, cytarabine, cisplatin, or G-CSF. HIV antibody or HBV-DNA is positive. Have severe uncontrollable disease(for example, cerebral disease, diabetes mellitus, or severe psychological diseases). Considered as inadequate for this study by study director, or members of this study.

Design outcomes

Primary

Measure	Time frame
overall response rate after therapy (CR and PR on PET-CT)	—

Secondary

Measure	Time frame
collected number of CD34 positive cells/adverse events/Overall survival/relapse-free survival	—

Countries

Japan

Contacts

Public ContactTakayuki Shimizu

Keio University Department of Hematology

taka-sh@keio.jp03-3353-1211

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Safety and efficacy of BV-ESHAP therapy for relapsed and refractory Hodgkin&#39;s lymphoma before transplantation