HEMATOLOGY

The accrual of NCCTG Hematology Group cancer treatment protocols to date has been 165 patients since January 1, 1996 with an average of 41 patients per year. An additional 162 patients have entered our randomized study of erythropoietin for anemic patients on chemotherapy. Eight studies have been activated during this time period, four have been completed, six are currently active, and six new protocols will be activated in early 2000. If all protocols that are currently are activated as planned by early 2000, we will have 12 NCCTG Hematology protocols open in 2000. The group has published one manuscript on the results of a CLL trial (93- 81-51) that tested chlorambucil and 2-CDA for patients with active, previously untreated disease (Tefferi et al., American Journal of Clinical Oncology 22(5):509-516, 1999). Dr. David Inwards recently presented at the annual meeting of the American of Hematology the results of NCCTG 95-80-53 which studied 2-CDA as initial treatment for previously untreated mantle cell lymphoma and these results are now published in abstract form (Blood 94 (10) Suppl 1 (660A), 1999). Several studies have met their targeted accrual, are closed, and are awaiting final analysis before submission in abstract and full manuscript form. Tumor cells from patients entering the NCCTG CLL trials have been used for ancillary laboratory investigations that have focused on cytogenetic abnormalities detected in tumor cells using fluorescence in situ investigations that have focused on cytogenetic abnormalities detected in tumor cells using fluorescence in situ hybridization (FISH) and detection of surface markers and adhesion molecules by flow cytometry. The results of our study of syndecan-1 (co-receptor for fibroblast growth factor) expression of malignant B-cells have been published (Leukemia and Lymphoma 31:1267-175, 1998). During the past two years, it has become apparent that the number of patients entering NCCTG Hematology protocols was too low. The primary reason for the inadequate accrual was a lack of open protocols rather than poor accrual to open studies. The small number of active studies was not anticipated and is due to several reasons: 1) some important pilot studies at the Mayo Clinic research base did not show adequate activity to warrant full NCCTG trials; 2) four approved trials have been able to open because of failure to obtain drug from pharmaceutical sponsors; 3) competition from ECOG has limited the number of protocols in multiple myeloma and acute leukemia. Interest on the part of the community hematologists remains high in support of NCCTG Hematology, because the protocols do indeed address tumor sites (such as CLL and NHL) that they see on a routine basis. Because of lack of accrual, it was recommended by External Advisory Group that Hematology not be included as a full program in the February, 2000, grant submission; however, Hematology will continue as a working group with the aim of activating all of the protocols in development by Spring, 2000. We then plan to resubmit an out-of-cycle request for financial support to the National Cancer Institute as a full program in 1-2 years. We have developed a plan to strengthen the NCCTG Hematology Program by 1) increasing the number of active protocols; 2) focusing our efforts on the B-cell malignancies, myelodysplastic syndromes, and myeloproliferative disorders; 3) increasing the FTE commitment to the Hematology Program; and 4) shortening the protocol development and activation time. We fully intend to establish a solid track record over the next few years which will justify submission for NCI support of an NCCTG Hematology Program.