Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003794

Trial Description

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Title

First International Inter-Group Study for Classical Hodgkin's Lymphoma in Children and Adolescents

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer
cells, either by killing the cells or by stopping them from dividing. Giving more than one
drug (combination chemotherapy) may kill more cancer cells. It is not yet known which
combination chemotherapy regimen is more effective in treating Hodgkin's lymphoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy
regimens to compare how well they work in treating young patients with Hodgkin's lymphoma.

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Brief Summary in Scientific Language

OBJECTIVES:

Primary

- Determine whether the 5-year event-free survival (EFS) rate in pediatric patients with
Hodgkin's lymphoma with an adequate response after 2 courses of vincristine, etoposide,
prednisone, and doxorubicin hydrochloride (OEPA) (without radiotherapy) are consistent
with an estimated target EFS rate of 90%.

- Compare the EFS (without a deterioration) of patients treated with procarbazine
hydrochloride vs dacarbazine (treatment groups 2 and 3).

- Determine the treatment outcome of a standardized risk-adapted relapse strategy in
these patients.

Secondary

- Determine whether the 5-year EFS rate in patients with Hodgkin's lymphoma with an
inadequate response after 2 OEPA courses and standard involved-field radiotherapy are
consistent with an estimated target EFS rate of 90%.

- Determine whether a positive positron emission tomography scan before planned high-dose
chemotherapy with autologous stem cell transplantation has a negative prognostic
significance.

- Compare the effect of dacarbazine vs procarbazine on the rate of infertility in males
and premature menopause in females (treatment groups 2 and 3).

Tertiary

- Determine the impact of real-time central staging and response assessment on treatment
outcome in these patients.

OUTLINE: This is a randomized, controlled, parallel-group, open-label, multicenter study.
Patients are stratified according to staging and response assessment (central vs local) and
disease stage (IA/B or IIA [first-line treatment group 1] vs I_EA/B, II_EA, IIB, or IIIA
[first-line treatment group 2] vs II_EB, III_E A/B, IIIB, or IVA/B [first-line treatment
group 3]).

- First-line treatment group 1: Patients receive oral prednisone (or prednisolone) 3
times daily on days 1-15, vincristine IV on days 1, 8, and 15, doxorubicin
hydrochloride IV over 1-6 hours on days 1 and 15, and etoposide (or etoposide
phosphate) IV over 1-2 hours on days 1-5 (OEPA).

Treatment repeats every 28 days for 2 courses in the absence of unacceptable toxicity.
Patients are assessed by fludeoxyglucose F 18 positron emission tomography (^18FDG-PET)
scan. Patients with inadequate response undergo radiotherapy within 35 days after completion
of OEPA.

- First-line treatment group 2: Patients receive OEPA as in group 1. After completion of
OEPA, patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral prednisone (or prednisolone) 3 times daily and oral
procarbazine hydrochloride 2-3 times a day on days 1-15 and vincristine IV and
cyclophosphamide IV over 1 hour on days 1 and 8 (COPP).

- Arm II: Patients receive oral prednisone (or prednisolone) 3 times daily on days
1-15, dacarbazine IV over 15-30 minutes on days 1-3, and vincristine IV and
cyclophosphamide IV over 1 hour on days 1 and 8 (COPDAC).

In both arms, treatment repeats every 28 days for 2 courses in the absence of unacceptable
toxicity. Patients are assessed by ^18FDG-PET scan. Patients with an inadequate response
undergo radiotherapy within 35 days after completion of COPP or COPDAC.

- First-line treatment group 3: Patients receive OEPA as in group 1. After completion of
OEPA, patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive COPP as in arm I of group 2.

- Arm II: Patients receive COPDAC as in arm II of group 2. In both arms, treatment
repeats every 28 days for 4 courses in the absence of unacceptable toxicity.
Patients are assessed by ^18FDG-PET scan. Patients with an inadequate response
undergo radiotherapy within 35 days after completion of COPP or COPDAC.

Patients with biopsy-confirmed disease progression OR relapse after first-line treatment on
this study or on protocols DAL-HD 90, GPOH-HD 95, GPOHHD 2002 Pilot, or similar treatment
proceed to second-line therapy. Patients are stratified according to relapse/progression
status (late relapse from first-line treatment group 1 [second-line treatment group 1] vs
early relapse from first-line treatment groups 1, 2, or 3 or late relapse from first-line
treatment groups 2 or 3 [second-line treatment group 2] vs disease progression [second-line
treatment group 3]). Patients undergo a ^18FDG-PET scan prior to beginning second-line
therapy.

- Second-line treatment group 1: Patients receive ifosfamide IV over 22 hours and
etoposide IV over 1-2 hours and oral prednisone three times daily on days 1-5 (IEP).
Patients then receive doxorubicin hydrochloride IV over 1-6 hours, bleomycin IV,
vinblastine IV, and dacarbazine IV over 15-30 minutes on days 22 and 36 (ABVD).
Treatment repeats every 50 days for 2 courses in the absence of disease progression or
unacceptable toxicity.

After chemotherapy treatment, patients undergo radiotherapy.

- Second-line treatment group 2: Patients receive IEP and ABVD as in group 1. Autologous
stem cells are collected after course 1 or 2 of IEP/ABVD.

After chemotherapy, patients with an adequate response undergo radiotherapy. Patients with
an inadequate response undergo high-dose chemotherapy comprising carmustine IV over 1-2
hours on day -7, etoposide IV and cytarabine IV over 30 minutes twice daily on days -6 to
-3, and melphalan IV over 1½ hours on day -2. Patients then undergo autologous hematopoietic
stem cell transplantation (HSCT).

Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive
disease undergo radiotherapy.

- Second-line treatment group 3: Patients receive IEP and ABVD as in group 1. All
patients then undergo high-dose chemotherapy and HSCT as in group 2.

Patients undergo a ^18FDG-PET scan on day 50-54. Patients with ^18FDG-PET scan positive
disease undergo radiotherapy.

After completion of study therapy, patients are followed periodically for 5 years.

PROJECTED ACCRUAL: A total of 2,150 patients will be accrued for this study.

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Organizational Data

  •   DRKS00003794
  •   2012/11/16
  •   2007/02/08
  •   yes
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Secondary IDs

  •   2006-000995-33 
  •   NCT00433459  (ClinicalTrials.gov)
  •   CDR0000531687  (Martin-Luther-Universität Halle-Wittenberg)
  •   EURONET-PHL-C1 
  •   EU-20703 
  •   CCLG-HD-2007-10 
  •   EUDRACT-2006-000995-33 
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Health Condition or Problem studied

  •   Lymphoma
  •   C81 -  Hodgkin's disease
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Interventions/Observational Groups

  •   Biological: bleomycin sulfate
  •   Drug: carmustine
  •   Drug: cyclophosphamide
  •   Drug: cytarabine
  •   Drug: dacarbazine
  •   Drug: doxorubicin hydrochloride
  •   Drug: etoposide
  •   Drug: etoposide phosphate
  •   Drug: ifosfamide
  •   Drug: melphalan
  •   Drug: prednisolone
  •   Drug: prednisone
  •   Drug: procarbazine hydrochloride
  •   Drug: vinblastine sulfate
  •   Drug: vincristine sulfate
  •   Procedure: autologous hematopoietic stem cell transplantation
  •   Radiation: fludeoxyglucose F 18
  •   Radiation: radiation therapy
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
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  •   III
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Primary Outcome

- Event-free survival

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Secondary Outcome

- Overall survival
- Progression-free survival
- Toxicity
- Evidence of male infertility score
- Evidence of female sexual functioning score
- Long-term consequences (e.g., premature menopause, secondary cancer)

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Countries of Recruitment

  •   Germany
  •   United Kingdom
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Locations of Recruitment

  •  
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Recruitment

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  •   2007/01/31
  •   2150
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   17   Years
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Additional Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed classical Hodgkin's lymphoma

- No lymphocyte-predominant Hodgkin's lymphoma

- Fine-needle biopsy not sufficient

- No prior treatment for Hodgkin's lymphoma except for recommended pre-phase therapy
for a large mediastinal tumor

PATIENT CHARACTERISTICS:

- No known hypersensitivity or contraindication to study drugs

- No other current malignancy

- No severe concurrent disease (e.g., immune deficiency syndrome)

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for up to 1 year after
completion of study treatment

- No known HIV positivity

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy or radiotherapy

- At least 30 days since prior and no other concurrent investigational drugs or
participation in another investigational trial

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Exclusion Criteria

[---]*

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Addresses

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    • Martin-Luther-Universität Halle-Wittenberg
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    • Martin-Luther-Universität Halle-Wittenberg
    • Dieter Koerholz, MD 
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    • Martin-Luther-Universität Halle-Wittenberg
    • Dieter Koerholz, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   109
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.